LAB QUALITY
RESOURCE GUIDE
Elevating Lab Quality:
Strategies for Accuracy,
Precision, and Reproducibility
Ensure compliance and achieve reliable results
with advanced tools and best practices
AUTOMATING MANAGING ENSURING COMPLIANCE
Sample and Liquid Handling and Securing Cold Storage in Weighing Applications
Assets
Table of Contents
3 Essential Tools for Precision and Efficiency in the Lab
4 Instrument Qualification and Software Validation are
Critical Compliance Steps
7 Staying Compliant Using Lab Balances
9 Precision and Capacity in Laboratory Balances
11 Successfully Maintaining Automated Liquid Handlers
13 Effective Cold Storage Management is Essential for
Protecting Valuable Assets
16 Cold Storage Security
18 Features to Consider When Buying a Laboratory Water
Bath
21 How to Prevent Biological Contamination in Your CO 2
Incubators
23 Centrifuge Sample Handling Puts a Renewed Focus on
Integrity
26 Proactive Lab Management with an Environmental
Monitoring System
2 Lab Manager Lab Quality Resource Guide
n
o
i
t
c
u Essential Tools for
d Precision and Efficiency
o in the Lab
Core technologies that streamline workflows, safeguard
r samples, and ensure reliable, high-quality lab operations
t Achieving precision, efficiency, and reliability requires the right tools and technologies. From
pharmaceuticals and biotechnology to environmental science and food safety, a range of core
technologies, such as balances, automated liquid handlers, cold storage, and environmental
n monitoring systems, support research and production.
I These technologies play a pivotal role in streamlining workflows, maintaining regulatory
compliance, and delivering consistent results with minimal error. Everyday instruments like
balances provide the precise measurements necessary for supporting compliance efforts.
Other instruments, like automated liquid handling systems and autosamplers, reduce human
error and variability in complex processes, allowing labs to increase throughput—a critical
advantage in high-demand laboratories.
Cold storage solutions and their integrated security systems are vital in preserving the in-
tegrity of valuable samples. Real-time alarms and other security features help prevent losses
from mechanical failures or tampering. Effective cold storage management requires proper
training, clear communication, regular monitoring, and preventative maintenance.
Real-time monitoring solutions, like environmental monitoring systems, enhance lab operations
by enabling proactive management. These systems centralize data from equipment and infrastruc-
ture to safeguard research environments and ensure controlled conditions for critical experiments.
This resource guide contains detailed insights into how core tools and technologies
support lab quality. It includes information on selecting and maintaining automated
liquid handling platforms, autosamplers, water baths, balances, and more. There
is also guidance on cold storage management and security to help labs safeguard
valuable samples. Lastly, the guide explores how environmental monitoring systems
can streamline lab management to optimize operations and prevent disruptions.
3 Lab Manager Lab Quality Resource Guide
Instrument Qualification
and Software
Validation are Critical
Compliance Steps
In order to offer a consistent and high-quality output,
regulated labs must implement these
by Scott D. Hanton, PhD
Highly regulated life science labs that operate under quality tests will document that the instrument is operating properly
systems like Good Manufacturing Practice (GMP), Good and delivering the expected data and outcomes.
Laboratory Practice (GLP), or Good Clinical Practice
(GCP) must document that the lab instruments and software Performance qualification (PQ)
will meet the needs of the lab and deliver the expected out-
puts. These processes are known as instrument qualification The performance qualification demonstrates that the new
and computer system validation (CSV). instrument consistently performs this needed activity in
the actual lab environment. Labs often document the PQ by
Instrument qualification running through a complete method, procedure, or protocol
that is commonly performed in the lab. The PQ documents
An effective approach to instrument qualification is provided that the new equipment performs the needed tests as expect-
in the US Pharmacopeia (USP) General Chapter <1058>, ed and consistently with the needs documented in the DQ.
1
“Analytical Instrument Qualification.” Instrument quali-
fication enables the lab to demonstrate that it acquired the Software validation
right equipment to solve a problem and deliver on a need for
a key stakeholder. The scope of the qualification is confined The US Food and Drug Administration (FDA) provides
to a specific piece of lab equipment. Following the USP ap- an effective approach to software validation in its guidance
proach a lab will conduct four different stages of instrument document “General Principles of Software Validation” dated
2
qualification: January 2002. This document provides guidance on how the
lab can be compliant to FDA 21 CFR Part 11. The purpose of
Design qualification (DQ) software validation is to confirm that the software consis-
tently produces results meeting predetermined acceptance
The design qualification defines the need for the instrument criteria. For lab software the key components of the valida-
by the lab. It will clearly describe the problem that needs to tion ensure that the data are reliable, accurate, and secure.
be solved for both technical and regulatory purposes. The Important things for the lab to consider during the validation
lab will generate a set of user requirement specifications process are data integrity, effective audit trails, how they
(URS) that clearly document how a potential solution will control user access, ensuring unique electronic signatures,
solve the problems. The DQ enables the lab to clearly define and appropriate system maintenance.
the problem, the need, and how a specific solution will solve
the problem and meet the need. The key driver of software validation is regulatory compli-
ance. However, the lab also gains the benefits of ensuring
Installation qualification (IQ) data integrity, improving lab quality, and of mitigating risks
associated with potential software failures
The installation qualification verifies that the option selected
to meet the needs and solve the problem is properly installed. Since most modern lab instruments contain software, or
It also documents that the lab environment is appropriate for are run by computers with specific software, the computer
the instrument to operate properly and deliver the needed validation usually follows the instrument qualification. Once
data. The IQ enables the lab to document that the new piece the qualification determines that the hardware is ready, then
of equipment is fully installed and will operate according to the software is examined. Some common steps for software
the manufacturer’s specifications. validation are:
Operational qualification (OQ) Scope and purpose
The operational qualification confirms that the installed in- Document the scope of the validation. Specify which func-
strument operates as expected and intended under the exist- tions of the software are being installed and used by the
ing operating conditions. From the URS the lab can develop lab. Limit the validation project to the things the lab will
test scripts that will functionally test the new instrument consistently need and use. Link the scope to the key needs
against well-established standards. The outcomes of these that drove the acquisition.
5 Lab Manager Lab Quality Resource Guide
“Instrument qualification enables regulatory auditors that specific software is compliant with
the lab to demonstrate that it their requirements.
acquired the right equipment to Equipment qualification and software validation are big
projects for labs. It can take longer to complete the qualifi-
solve a problem and deliver on a cation and validation steps than it does to identify the need,
advocate for investment, win approval, and obtain the new
need for a key stakeholder.” equipment or software. Developing templates and building
internal expertise can greatly improve the efficiency of these
processes. It is also important to consider external partners
A best practice of software validation is using a risk-based who can do some or all of these processes for the lab as con-
approach to the project. Focus on the critical parts of the tract partners.
programs and processes. The International Society of Phar-
maceutical Engineering provides and effective approach to References:
3
risk-based software validation in GAMP 5. 1. https://doi.usp.org/USPNF/USPNF_M1124_01_01.html
Regulatory framework 2. https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/general-princi-
Ensure compliance with the regulatory requirements under ples-software-validation
which the lab operates. Ensure a clear understanding of the
regulations pertaining to your lab. If your lab is regulated by 3. https://ispe.org/publications/guidance-documents/gamp-
the FDA, ensure that electronic records, dynamic data, and 5-guide-2nd-edition
electronic signatures are part of the validation project.
System development life cycle
The system development life cycle will establish the
required specifications of the software to meet the lab’s
needs and be compliant with the regulations. The lab can
document that the new software is consistent with those
requirements. It guides the lab through testing the software
to ensure that it meets those requirements and functions
properly during use.
Traceability matrix
The traceability matrix uses lab developed test scripts to
document that the software complies through the actions
required by the lab. Developing a complete set of test scripts
can be a tedious and difficult task. It is important to remove
any duplication between different test scripts to reduce the
time required to validate the software.
Validation report
The validation report is the final documentation of all of the
effort invested by the lab in the software validation. It sum-
marizes all the actions, findings, and outcomes of the project.
This report will be the primary vehicle to demonstrate to
6 Lab Manager Lab Quality Resource Guide
Staying Compliant Using
Lab Balances
In regulated work, balances must be compliant and create an audit trail
By Mike May, PhD
Many processes in a biopharmaceutical lab depend on data signatures, and safe data-transfer options for integration
from analytical balances. In regulated work, balances must into software systems like a laboratory information manage-
be in compliance and create an audit trail. ment system or electronic notebook. User assignments allow
records to be traced in an audit trail and limit users to the
Usually, these balances must meet the data integrity guidelines processes required in their work.
of more than one regulator worldwide. In the United States, a
biopharma balance must meet the US Food and Drug Admin- Weighing the options
istration’s 21 Part 11 requirements. In the European Union, the
key balance guidelines come from the EU Annex 11. An important feature for compliance is the ability to save
and transfer data, which requires Wi-Fi capabilities or a
To meet these guidelines, the instrument should include hardware interface, such as Ethernet, RS-232, or USB. These
features for managing users and their roles, electronic interfaces provide an analytical balance with communication
7 Lab Manager Lab Quality Resource Guide
capabilities that allow it to interact with other instruments Part of being consistent in taking care of a balance means
in a lab. Plus, a balance’s software can ensure that it stays regularly reviewing the data that it collects. In such reviews,
compliant with the required guidelines, such as those from scientists can look for signs of malfunction or violations of
the FDA or EU. data integrity.
Even selecting a balance based on its screen can simplify Time is crucial to compliant weight measurements. The correct
life in the lab. For example, a balance with a color capacitive time is essential for a proper audit trail, so it should be checked
touchscreen can be used by gloved personnel. Otherwise, at least once a month. This can be handled automatically by
some users would need to remove gloves to interact with a setting up a time synchronization through a connected network.
balance, put gloves back on to work with samples, and possi-
bly repeat that process all day. Beyond time, other features of a balance can also be checked
automatically. In some balances, this includes an automatic
Keep it compliant check for leveling, adjustment, and calibration before every use.
If a balance is out of specification, some software can even block
An analytical balance requires maintenance to stay in com- weighing until the instrument is repaired or simply adjusted.
pliance and create an accurate audit trail. In addition, only
a regularly maintained and calibrated balance can perform As one last bit of advice, never forget to clean the balance regu-
optimally for a long time. larly. It’s not the case that clean is compliant, but it never hurts.
Proper Analytical Achieve Accuracy
Balance Practices
ACCURATE MEASUREMENTS REQUIRE RELIABLE SCALES with Best Practices for
Keep your balance calibrated
Correct analytical balance calibration is essential to maintaining
accurate results. Calibration is often done using a predefined Analytical Balances
calibration weight for external calibration. If your balance has
internal calibration, it can be carried out quickly with the push
of a button—without the use of calibration weights.
Keep your balance clean When it comes to analytical balance practices,
It is critical to gently wipe down your balance after each use, anything left under the weighing
pan can affect accuracy. precision is paramount. Across many lab
Begin by putting on appropriate PPE.
1 Make sure the balance
is switched off and remove
2any power supply cables. environments—from research and development to
Remove the draft shields and weighing pan
and clean them with a soft, non-abrasive
cloth and a mild cleaning solution. quality control—maintaining strict adherence to proper
Wipe away powder or dust, but do
3not use air since it could blow the
dust into the mechanism.
Put the balance back together balance practices is crucial for obtaining reliable,
after it has thoroughly dried,
then calibrate it.
4 0 0 0 0 0 0
reproducible results.
Precautions for accurate weighing
LOCATION, LOCATION, LOCATION Explore the essential elements of proper analytical
Drafts are a serious issue for balances—even those with enclosed weighing
compartments. The higher the required resolution or accuracy the more
care must be taken.
A balance must be placed in the right location to avoid drafts and vibrations balance use, including calibration, maintenance, and
—away from open windows, doors, and heavily trafficked areas of the lab.
It should also be placed on a heavy table that is away from equipment that
produces vibrations.
ENSURE AN APPROPRIATE ENVIRONMENT sample handling techniques, to optimize your weighing
Changes in temperature, humidity, and air pressure all affect balances,
but temperature changes are the most serious. Warming can reduce mass
while cooling can increase it. To overcome this problem, allow the sample,
vessel, and balance to reach an equilibrium whenever temperature
differences are suspected. practices and ensure accurate outcomes.
Low humidity can promote static buildup in samples that reacts with metal
components to create serious drifts. These samples may never achieve stability.
Try to avoid glass or plastic vessels that promote static or invest in accessories
that help eliminate it.
HANDLE CALIBRATION WEIGHTS PROPERLY
These weights should never be touched with bare hands as fingerprints
and grease can cause errors in the readings. Always use a pair of clean wooden
or rubber-tipped forceps while moving the weights—gloves can be used when
handling heavy weights. After use weights should be stored in a moisture
and dust-free room.
TAKING SAMPLE MEASUREMENTS
Use a clean spatula to place the sample into an appropriate vessel.
Before recording any readings allow them to stabilize. When weighing
small amounts of samples, extra precautions—like wearing disposable
gloves, head caps, and a face mask—should be taken. The sample should
also be placed in the center of the balance.
8 Lab Manager Lab Quality Resource Guide
Precision and Capacity
in Laboratory Balances
A wide array of precisions, capacities, and features add
up to balance options for every type of laboratory
by Brandoch Cook, PhD
There are a few pieces of equipment that every lab needs “Laboratory balances fall into three
regardless of its size or the application in which it is engaged. broad categories that differ in
A laboratory balance resides around the top of this list. For
research labs, the integrity and quality of every buffer are configuration, sensitivity, and capacity:
dependent upon the balance’s accuracy and usability. For
analytical labs, identification and characterization are only top loading, precision, and analytical.”
possible if starting quantities are dependable. For pharma
labs and drug discovery, compliance and adaptability to
evolving regulatory standards and guidelines are as essential theless, there is a wide variety of precision and analytical
as the ability to detect changes in mass at infinitesimal scales. balances that can include features like automated draft
shields, internal calibration that accounts for latitude and
Laboratory balances fall into three broad categories that altitude, and the ability to report weights in many different
differ in configuration, sensitivity, and capacity: top loading, international and commercial units.
precision, and analytical. Top loading balances employ an
open configuration with a large pan to accommodate various These and other options can drive purchasing decisions that
weigh boats. They have the highest capacity with the lowest are unique to each type of laboratory. Internal calibration
precision of readability, usually differences of 0.01 g (10 mg). and lock-out with user authentication can strengthen an
They are the workhorses of research labs and are used to audit trail and facilitate regulatory compliance. Increased
create most buffers, requiring dissolution of tens or hun- connectivity to external devices via USB ports allows in-
dreds of grams of powder. When an investigator prepares vestigators to streamline analytical procedures. The latest
reagents for agarose gels and western blotting experiments, technology in balances also allows custom configuration,
the top loading balance is an important piece of equipment. including draft shields with ionizers to reduce static electric-
Although most have capacities of five to 10 kg, there are ity while weighing precious powders. With a vast array of
specialized high-capacity instruments that can measure precisions, capacities, and features, there is a perfect balance
weights up to 70 kg, convenient for taring large vessels. for every laboratory.
The undersides of some balances reveal an underhook that
can be used to weigh materials that cannot be traditionally
measured, such as oversized or irregularly shaped objects
and magnetic materials that would interfere with the force
restoration mechanisms used in contemporary high-quality
balance design.
It is true for all balances that as capacity increases, sensitivi-
ty decreases. Although analytical and precision balances are
similar to each other in outward design, they typically differ
by an order of magnitude of readability, 0.0001 compared to
0.001 g (1 mg), respectively. Precision balances are, therefore,
often called “milligram scales.” The outward characteristics
that distinguish both from top loaders are smaller weigh
pans and draft shields that isolate samples and powders from
interference during weighing. In terms of utility, however,
they are both adept at handling much smaller tasks. Ana-
lytical balances often have maximum capacities of 220 g or
less and are useful for constituting solutions containing less
than a few grams in less than a few milliliters, for instance,
cytokine and small molecule inhibitor stock solutions. For
those invested in the seriously small, there are ultra-micro
balances with capacities of two grams that read accurately at
the nanoscale, although prices increase accordingly. None-
10 Lab Manager Lab Quality Resource Guide
Successfully Maintaining
Automated Liquid Handlers
Liquid handlers require regular maintenance for consistent, reliable results
By Sachin Rawat
Most operations in a laboratory involve moving around various However, automation doesn’t necessarily mean error-free,
amounts of liquids. While manually doing this is practical for and care needs to be taken to ensure the reliable operation of
smaller experiments, biology is increasingly high throughput. automated liquid handlers (ALHs).
Experiments in fields like omics, pharma, and systems biology
involve parallel handling of hundreds or thousands of samples. Common problems
Unlike manual pipetting, automated liquid handling systems Over time, wear and tear lowers the accuracy of liquid han-
can do this quickly, allowing researchers to spend more dling systems. These are often visible on closer inspection as
time on other tasks. Capable of sophisticated operations like kinks or bends in the tubing, loose fittings, uneven heights of
reformatting, cherry-picking, and aliquoting, they are also the pipette tips, and obstructions to moving parts. Other-
cost-efficient and offer high repeatability and precision. wise, uneven dispensing or errors in liquid transfers along
11 Lab Manager Lab Quality Resource Guide
the edges or in particular rows or columns of microtiter Best practices
plates could hint at malfunctioning of certain parts.
) Clean permanent pipette tips regularly to prevent con-
Errors in liquid transfer also show up as random or periodic tamination from the residual reagents
variability in data or loss of signal over time. If unnoticed,
these errors could propagate to downstream operations, ) Clean between transfers (in protocols with sequential
wasting time and resources. Routine maintenance can pre- dispensing steps)
vent these errors from creeping in.
) Choose the appropriate disposable pipette tips based
Contamination is a major problem with automated liquid on the properties of the liquid
handling systems. Reagent residues may build up on pipette
tips, or some liquid may carry over from one step to the next. ) Adjust the pipetting parameters according to the
Another common problem is that they might aspirate or sample type
dispense incorrect volumes. This could be due to prolonged
shear forces on the pipette tips, reagent build-up, or envi- ) Monitor performance using gravimetric and/or photo-
ronmental factors. For example, humidity, temperature, and metric measurements
vibrations can alter liquid properties, leading to variations in
measurements from different batches or machines. Minimiz- Lastly, to prevent costly repairs, moving parts of liquid
ing these disturbances in the laboratory space and following handling systems should be routinely inspected, and compo-
best practices in handling ALHs are key to extracting the nents like tubes, valves, and pumps replaced when necessary.
most value from them. Following best practices and regular maintenance ensures
that ALHs deliver reliable and reproducible data.
12 Lab Manager Lab Quality Resource Guide
Effective Cold Storage
Management is
Essential for Protecting
Valuable Assets
Miscommunication, improper usage, and
misunderstandings can compromise valuable materials
in cold storage
by Marnie Willman
A recent article published in the New York Times describes “Personnel safety is of the utmost
every researcher’s worst nightmare: A freezer full of thawed
materials. The university lab recounted the experience in importance in the lab, but there
painful detail, describing a series of unfortunate events that
led to the perfect storm. Such circumstances are not un- is also an element of protection
common, underscoring the importance of proper training,
equipment monitoring, and clear communication in the lab. needed for the equipment, samples,
As the affected lab begins to rebuild their stocks again, it’s
time for other research teams to look to their own pro- and other lab fixtures as well.”
cesses, identify similar gaps, and make efforts to prevent a
similar misfortune.
awry can protect precious assets and save the heartache of
Training: Strength begins at the base losing materials gathered over many hours of work.
Personnel safety is of the utmost importance in the lab, but Depending on the time it has taken to generate stocks or
there is also an element of protection needed for the equip- other materials kept in the freezer, it may be worth consid-
ment, samples, and other lab fixtures as well. To ensure that ering dual locations for storage of some items. Storing your
everyone and everything is well protected, adequate training valuable materials in more than one freezer reduces the risk
with routine follow-ups is necessary. Refresher training to of loss, especially if the first freezer has been fluctuating or is
keep all staff aligned in their practices and ensure that new otherwise not functioning optimally.
techniques and procedures are adopted sufficiently should be
a regular occurrence. Checking equipment should be part of
a weekly routine
In the case of the university freezer mishap, a lack of training
may have contributed to janitorial staff mistakenly turning Academia or industry, big or small—regular monitoring of
off a breaker powering the freezer. Custodial staff are also any lab must be performed. In many cases, equipment may
part of the lab and require some training when it comes to be located in an area of the lab that is not often used, or
the equipment they handle and the areas of the lab they perhaps outside of the lab entirely because of existing infra-
interact with. structure. Many labs find it easiest to have a weekly routine
for cleaning and maintenance tasks. This ensures a small
Regular freezer monitoring and proper portion of the lab is not doing the lion’s share of the work and
storage protect lab materials delegates the responsibility of these essential jobs. Check-
ing freezer temperatures and ensuring seals and pumps
Regular monitoring is always important, but when problems are working, temperatures are stable, and problematic frost
arise, speed is of the essence. For example, in the original buildup is not occurring should be part of this weekly check.
case covered in the Times article, their freezer alarm was Taking a few minutes to monitor the status of a freezer hold-
sounding. A repair technician had been called, but the alarm ing valuable materials is well worth the time.
continued to sound in the interim. The problem came when
a custodial staff member shut off the breaker to the freezer, Effective, consistent communication is
mistakenly thinking that the freezer was alarming because essential
the breaker was off and that he was solving the issue by
switching it back on. Good communication in the lab goes far beyond making
sure the right tasks are done. Holding regular meetings and
This event provides a good example of why it’s unwise conversations with staff members prevents miscommunica-
to leave a repair longer than absolutely necessary. While tions that can lead to dire consequences. Keeping all staff
waiting a short time for a repair technician, the contents of informed and up to date will reduce the risk of errors that
the freezer were entirely lost when it was mistakenly shut off. can cost the lab. Loss of materials, inefficiency, experiments
In similar circumstances, monitoring freezers and ensuring needing unnecessary repetition, and duplication of work by
diligent signage and communication when things have gone different staff members can result from miscommunications.
14 Lab Manager Lab Quality Resource Guide
Sometimes signage is not enough—people often fail to read reagents, stocks, and other valuables are kept is functioning
and remember signs as they’re preoccupied with their work. properly is essential for the workings of the lab. Many people
Regular meetings to reinforce standard operating procedures from lab managers to students to custodial staff are involved
and the importance of regularly checking equipment will in the use and maintenance of cold storage, making clear
go far in curbing problems. Clear communications with all communication and equipment maintenance that much more
lab members, including custodial staff, may prevent future important. The incident in the laboratory that lost 20 years
accidents like this in addition to the aforementioned savings. of research products was not the fault of one single factor.
Effective management through implementation of the above
There are many factors involved in cold actions will keep laboratories running smoothly, increasing
storage maintenance productivity and output, and preventing the headache and
heartache of lost frozen materials.
Cold storage is an often overlooked but vital component of
the lab. Making sure that the storage where cells, microbes,
15 Lab Manager Lab Quality Resource Guide
Cold Storage Security
Proper security measures for cold storage units are essential for safeguarding
valuable contents
By Aimee Cichocki
Cold storage solutions—from primitive ice houses to ultra-low equipment from the perspective of operational settings and
temperature freezers—have been essential to humans for cen- remote monitoring.
turies. They now play a huge role in a range of industries, in-
cluding food, pharmaceutical, and medical. For example, cold On the one hand, there are physical access concerns such as
storage is required for storing embryos, blood, plasma, and those surrounding tampering or theft. But you also need to
research materials such as RNA, DNA, enzymes, and reagents. safeguard the integrity of the contents. Allowing samples,
drugs, and other cold storage contents to go above or below a
With so many important applications, it’s crucial to con- certain temperature can render them useless.
sider the impact when these systems are compromised.
Cold storage security is a hot topic with many and varied To keep the contents of cold storage systems safe, there are
solutions. The term “security” is about more than just the a number of security features available, including backup
physical access security of the device. It is about protecting systems, alarms, remote monitoring, and access codes.
16 Lab Manager Lab Quality Resource Guide
Why cold storage security is important “To keep the contents of cold storage
Cold storage security is vital for several core reasons, includ- systems safe, there are a number of
ing ensuring the stability of stored samples and protecting
contents against physical access by unauthorized parties. security features available, including
Security is important in ensuring consistent experimental backup systems, alarms, remote
outcomes. For example, incorrectly stored reagents or cell
lines could lead to reduced viability or varied results. Aside monitoring, and access codes.”
from hampering efforts to achieve accurate results, inade-
quate storage can extend project times and increase costs.
To safeguard operational settings, experts recommend using
Although financial losses are important, there is intangible a password or passcode and making use of remote monitor-
value in some of the contents of cold storage systems. For ing, such as remote alarm contacts or temperature outputs.
example, inappropriate storage within in vitro fertilization
laboratories has led to loss and legal action. Vaccine storage A robust alarm monitoring system should monitor param-
is another example, as inappropriate storage can lead to eters such as temperature, alarms, door openings, and me-
spoilage, delays, shortages, and financial losses. chanical viability. These systems are even more effective if
they can be monitored remotely—for example, through push
Then there are physical access risks. In December 2020, notifications on your smartphone.
Interpol warned about potential criminal activity related
to the theft of COVID-19 vaccines. Physical security is also For protection against tampering and theft, secure access
particularly important for the storage of narcotic drugs and codes or key cards are popular options. Some systems take
other substances of abuse. advantage of technological advances such as using biomet-
ric authentication.
Another important factor to consider is the required secu-
rity protocols—for example, GMP (good manufacturing
practices). These will depend on which quality departments
or agencies a business needs to comply with, such as the
FDA. These protocols pertain to both physical security
mechanisms and the logging of access to ensure traceable
audit trails for the equipment and ultimately the contents
stored within.
Security options available for cold
storage solutions
There are two main aspects to cold storage security: con-
trolling physical access to contents and ensuring contents
remain at the right temperature.
When it comes to temperature control, a backup system is
arguably the most important component. Liquid nitrogen or
carbon dioxide backup systems on -80°C storage devices can
ensure temperatures don’t rise above critical levels during an
energy interruption or mechanical breakdown. Power backup
systems can help avoid outages and voltage boost or buck
systems can circumvent voltage spikes or drops that may
cause downtime or mechanical damage.
17 Lab Manager Lab Quality Resource Guide
Features to Consider
When Buying a
Laboratory Water Bath
From construction material to accessories, numerous
options are available
by Erica Tennenhouse, PhD and Mike May, PhD
Although typically used for heating and thawing in cell covers that allow one to retrieve samples without having to
culture, water baths have a variety of applications in research place the cover (likely dripping with condensation) on the
labs, from material characterization to histological studies. lab bench.
Whatever the application, those thinking of purchasing a
new water bath for their lab should consider the range of Beyond contamination prevention, lab managers should
available features that can facilitate safety, help avoid con- look for features that make the water bath simpler to use,
tamination, and make the unit flexible and easy to use. including digital controls, integrated timers, and the ability
to operate in both Fahrenheit and Celsius. Because baths are
Over-temperature limiters and audible alarms that warn typically shared within the lab, having presets can make it
users of extreme temperatures are two important factors for more convenient to switch settings between users. A cali-
water bath safety. One situation that is best avoided is having bration feature can also save time and money by removing
the heater remain on after all the water in the bath has evap- reliance on a third-party company to perform calibration.
orated. It is therefore important to have a safety mechanism
in place that can automatically turn the system off when dry A water bath must be flexible enough to accommodate the
running is detected. Additionally, buyers concerned with range of samples and devices that will be placed inside it,
safety should seek out UL-listed water baths and look for CE from test tubes to test tube racks to flasks of all different
and CSA certifications as well. sizes. For example, if users want to incubate an Erlenmeyer
flask that is taller than the depth of the bath, they require
a lid that can be configured to allow the neck of the flask
“Regularly draining and replacing to stick out but still cover the rest of the bath to minimize
evaporation.
the fluid in the water bath is another
key way to avoid contamination, and Finally, a feature that should not be overlooked is the avail-
ability of technical support.
buyers should consider how easy
that process is going to be.”
Consider a bead bath
When using a water bath, contamination prevention is essen- Labs can opt for metallic beads, which can avoid
tial, as a bath kept at 37ºC generates an ideal environment for splashing, dripping, and a majority of contamination
microbial growth. Certain features can reduce contamina- that can occur with water. However, metallic
tion risk. A fluoropolymer coating, for example, resists con- beads must still be cleaned properly to prevent
tamination. Having a stainless-steel reservoir is also a good contamination. Beads can also make it easy to hold
start, and transparent covers allow the user to observe the
a container at almost any angle without damaging
procedure without continually opening the bath. However,
users have additional options when it comes to the material the sample.
of construction. While stainless steel is the most common
material, ceramic interiors may be easier to keep clean.
Regularly draining and replacing the fluid in the water
bath is another key way to avoid contamination, and buy-
ers should consider how easy that process is going to be.
Whether the water bath has a drain built in, and whether the
drain is a simple valve that can be easily opened or requires
a screwdriver, can make a big difference for the user. Other
useful features include integrated drain hoses that make the
bath cleaner and easier to empty, along with removable hinge
19 Lab Manager Lab Quality Resource Guide
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20 Lab Manager Lab Quality Resource Guide
How to Prevent Biological
Contamination in Your CO
2
Incubators
Engineering and user controls help keep contamination at bay
By Andy Tay, PhD
Carbon dioxide (CO ) incubators are indispensable for biology 2 and contamination translates to a great loss of productivity.
work. They provide well-regulated CO levels, humidity, and 2 On the other hand, contamination involving mycoplasma is
temperatures that are ideal for cell and tissue culture. How- usually not noticeable at the early stages and is not detected
ever, the conditions that are optimal for your cells and tissues until experimental data show anomalies and must be dis-
are also likely to promote the growth of contaminating micro- carded. In general, contamination disrupts scientific prog-
organisms such as fungi, bacteria, mycoplasma, and viruses. ress, reduces the reliability of scientific data, and should be
minimized, if not prevented.
When biological contamination happens, it can adversely
affect the progress of research. For instance, some cellular In a 2010 report, biological contamination was found in close
systems like organoids take weeks if not months to grow, to nine percent of cell cultures in the biopharmaceutical
21 Lab Manager Lab Quality Resource Guide
industry. The statistics were even more alarming in academ- incubators above the ground so that microorganisms near
ic labs, with reportedly 80 percent of labs in Japan and 65 the floor and on the shoes of users do not enter the incubator
percent of labs in Argentina having experienced mycoplasma during opening and closing. Incubators should also be placed
contamination. Due to the prevalence of biological contami- further away from areas in the lab with high human traffic as
nation, a variety of control measures have been developed to the moving air may unintentionally introduce contaminants.
keep them at bay. Here, we share some of these tips that we Placing incubators away from direct sunlight helps to avoid
have broadly classified into engineering and user controls. temperature-induced condensation within the incubators
that microorganisms can exploit to grow.
Engineering controls
Second, laboratory personnel should practice aseptic tech-
Manufacturers have introduced a number of engineering niques when working with incubators. They should never
solutions to minimize biological contamination. touch the interior of an incubator with unsterilized gloves
or loose sleeves or speak into an incubator. Any items being
High-efficiency particulate air (HEPA) filters, on the interior placed inside the incubators should be sterilized with 70 per-
or exterior, are able to remove particles from outside air with cent ethanol and wiped down thoroughly. It is also important
diameters larger than 0.3 μm with more than 99.95 percent to keep door opening frequency to a minimum—before
efficiency before flowing the filtered air into the incubators. opening an incubator, users should spray the side of the door
Since mycoplasma is between 0.1-0.3 μm, HEPA filters can- and their gloves with 70 percent ethanol to sterilize surfaces
not filter them, and thus other engineering controls are need- that may be contaminated with microorganisms. Important-
ed. It is important to replace HEPA filters approximately ly, users should also be careful not to overfill an incubator
every six months as they can be clogged with large particles, with too many cell culture flasks and plates as this can
which reduces their filtering efficacy. disrupt proper airflow and temperature uniformity. When
temperature difference happens, condensation may occur
Newer incubators may also be equipped with automated heat within incubators, causing microorganisms to thrive.
decontamination and sterilization functions which provide
cleaning with the use of heat and steam. Annual inspection Finally, incubators should be cleaned on a weekly to monthly
is, however, recommended to ensure that this function is basis, depending on use, as this helps to remove potential
well-maintained. contaminants early before they become more serious. To
clean the interior of the incubator effectively, items in the
Other design features have been developed to minimize incubator should first be relocated to another incubator, free
biological contamination. Rounded corners make it easy for from contaminants. Then, it should be wiped down with a
users to identify and clean spills. Incubators made of copper non-corrosive disinfectant, such as 70 percent alcohol, pay-
can also minimize contamination, as copper has antimicrobi- ing special attention to high contact points. The water tray
al properties. Some newer incubators even come with ultra- should also be disinfected, and the water should be replaced
violet (UV) sterilization. Typically, 15 to 30 minutes of UV with sterile, distilled water. Tap water should be avoided as it
treatment will be sufficient for decontamination, but users often contains bacteria, and deionized water should be avoid-
should take note that this works only on surfaces that are in ed as well as it can corrode the metal pans. Copper sulfate or
contact with UV rays, and cells should be removed from the a quaternary ammonium disinfectant can also be added to
incubators prior to UV sterilization. the water pan to prevent the growth of microorganisms.
User controls CO2 incubators provide a well-regulated environment and
are a staple in many biology labs. There are multiple sources
Researchers are home to a rich ecosystem of microorganisms of biological contamination including the lab environment
and are the most likely source of contamination. By follow- (air and ground) and users, but with effective engineering
ing best practices, researchers can greatly minimize the risk and user controls, it is possible to keep contaminants at bay
of introducing biological contaminants into incubators. to generate reliable and reproducible scientific data.
First, incubators should be placed as far away from con-
taminants as possible. It is generally recommended to place
22 Lab Manager Lab Quality Resource Guide
Centrifuge Sample
Handling Puts a
Renewed Focus
on Integrity
Centrifuge consumables that incorporate advanced
materials and smart designs are impacting fields from
extractables to labs-on-chips
by Adam Dickie, PhD
Centrifuges have long been unsung workhorses of biology “Continuous innovation in centrifuge
and chemistry labs, but these machines are increasingly
coming into the spotlight with recent advancements that sample handling is driven by
have enabled researchers to investigate nanoscale systems,
improve production of drug delivery vesicles, and more. the need to couple improved
But as centrifuges implement new features, how are handling performance and automation with
systems keeping pace? In this article, we review some trends
impacting centrifuge sample formats. stricter control over sample integrity.”
Extractables and leachables
for minimizing protein adsorption onto polypropylene tubes
Most labs have foregone glass centrifuge tubes in favor of included silicone coatings or adding bovine serum albumin
the cost and convenience of plastic consumables typically to sample assays. Recent improvements in polypropylene
made from polypropylene—but recent research indicates synthesis, however, have enabled vendors to offer centrifuge
that chemical leaching from such sample holders may be an tubes specially designed to repel proteins and nucleic acids.
underestimated problem in life science applications. Others come with cleanroom sterility specifications and
certified free of DNase/RNase contaminants.
To combat against leachables and extractables, centrifuge
tube manufacturers recommend several different approaches. Some vendors offer solutions to ensure integrity when
Materials such as polycarbonates offer enhanced chemical working with higher-capacity formats as well. For instance,
resistance, while design changes such as thicker tube walls there are single-use and sterilized centrifuge bags available
can resist centrifugal forces. Vendors are also taking closer to minimize cross-contamination during harvesting and
looks at polypropylene supply chains, presenting products purification of components from bioreactors.
from virgin resin sources or with improved traceability.
Continuous innovation in centrifuge sample handling is
Biosafe centrifugation driven by the need to couple improved performance and
automation with stricter control over sample integrity. Lab
For users who prepare and store biomaterials such as cells managers can enhance data quality and streamline processes
inside centrifuge tubes, critical problems occur when plastic by adopting similar strategies in their workflows.
surfaces react with samples. Historically, typical solutions
24 Lab Manager Lab Quality Resource Guide
How to Choose the Right
Autosampler for Your Lab
The right autosampler can boost automation and research efficiency
Autosamplers provide automated sampling and injection to an analytical instrument for analysis. The amount
and rate of sample exchange can also be programmed according to the applications. Autosamplers are
increasingly being used by industry and diagnostic labs to improve the speed, precision, and accuracy of
sample processing and analysis. This is especially beneficial in labs performing high-throughput screening,
where they must analyze a large number of samples efficiently with little room for error. When chosen wisely,
autosamplers can make a huge difference in lab productivity.
When selecting an autosampler, consider the following factors:
Scale and experimental need
1 Evaluate whether your lab’s scale and experimental requirements justify the investment in an
autosampler. Consider both your current workload and future demands.
Throughput
2 Determine your lab’s throughput needs. Most liquid autosamplers can handle between 10 and a
few hundred samples.
Precision
3 Identify the degree of precision required for your application. Autosamplers vary in their precision
and accuracy, so understanding your tolerance levels is essential for consistent results.
Injection mode
Assess whether your lab needs fixed-loop and/or variable-loop injection modes. Fixed-loop
4 modes use a pre-set loop volume for consistent injections, making them ideal for routine
analyses. Variable-loop modes offer adjustable injection volumes by filling only a fraction of the
loop, providing greater flexibility for diverse applications.
Instrument compatibility
5 Confirm if the autosampler is compatible with your existing analytical instruments. This will ensure
seamless integration and optimal performance without additional modifications.
Proactive Lab
Management with
an Environmental
Monitoring System
The data afforded by an EMS facilitates more effective
lab management
by Holden Galusha
Environmental monitoring systems (EMSs) are facility-wide Discover opportunities for optimization
information platforms that harvest data from a variety of
sensors connected to lab equipment, infrastructure such as With an EMS, you see each asset and system as it exists in
HVAC and energy, and other sources to provide a complete relation to every other asset and system. This birds-eye view
picture of the health of the facility. Rather than siloing data of the lab gives you the perspective needed to see bottle-
across multiple programs, EMSs pull all the information necks, trace the root of inefficiencies and recurring problems,
together in one place. With this volume of information and formulate effective process changes that minimize unin-
readily available, lab managers are equipped to take a more tended consequences.
proactive approach to running the lab. Here are five ways
that lab managers can leverage an EMS to manage their lab Anticipate issues with greater foresight
more proactively:
The data collected in an EMS allows you to identify trends,
Make data-driven, holistic decisions which can illuminate issues such as equipment that is on its
way to failure. Armed with this data, you can see problems
An EMS provides an all-encompassing view of the lab at coming down the pipeline and address them preemptively,
multiple resolutions, ranging from the level of the entire minimizing disruption while ensuring product quality.
facility down to individual assets and equipment. There are
comprehensive data points at every layer. With this volume EMSs are a boon to any lab. Besides the benefits of real-time
and granularity of data, lab managers are empowered to status alerts and notifications, they enable lab managers to
make more informed decisions about lab processes. More take a more proactive, data-driven approach to running the
informed decision-making equates to more effective deci- lab, minimizing unforeseen hurdles and last-minute delays.
sions, which also increases the lab manager’s confidence in
leading the lab.
Ensure staff safety
Data-driven asset management
A good EMS will track much more than just the status of Environmental monitoring systems are an important
research equipment—they are directly wired to the facil- component of asset management. There are many
ity’s infrastructure and physical status at any given time.
For instance, the EMS continually monitors O levels, the types of data that can be captured and organized
2
presence of toxic or flammable chemicals, particulates, and for use in operational decision-making. Three main
more. With this information, embedded safety professionals categories are:
can develop effective protocols and be alerted when danger-
ous conditions arise. • Environmental and equipment monitoring
Maintain regulatory compliance • Instrument tracking
As mentioned, EMSs are data-dense, comprehensive systems. • Trend analysis
They simplify the process of collecting and compiling data All of these different data streams can be used to
as well as generating reports. This streamlined data handling
makes it considerably easier to ensure that the lab is compli- improve decisions and enable timely new actions to
ant with all relevant regulations—leaders, embedded safety address changing circumstances in the lab to save
professionals, and others have all the information on hand to money, enhance relationships, and better prioritize
ensure compliance. Furthermore, should an auditor request the use of time and assets.
information, it should be easy and fast to deliver, which will
serve to quicken the entire audit, keep lab operations on
schedule, and protect project timelines.
27 Lab Manager Lab Quality Resource Guide
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Waters Corporation, a global leader in analytical instruments and software, has pioneered
innovations in chromatography, mass spectrometry, and thermal analysis, serving life, materials, and
p food sciences for over 65 years. We ensure the efficacy of the medicines we take, the safety of
i the food we eat and the water we drink, and the quality of the products we use every day. With
approximately 7,900 employees worldwide, Waters operates in over 35 countries, including 15
manufacturing facilities, and has products available in more than 100 countries. Together with our
h customers, in labs around the world, we deliver scientific insights to improve human health and well-
being, helping to leave the world better than we found it.
s www.waters.com
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