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sampling isolator device set up in portable cleanroom
The custom-built portable sampling isolator developed by Plas-Labs in partnership with Hikma Pharmaceuticals.
Scott D. Hanton/Lab Manager

Custom Portable Sampling Isolator Improves Safety of Pharmaceutical Manufacturing

Plas-Labs creates custom portable sampling isolator for use in cleanrooms

by
Scott D. Hanton, PhD

Scott Hanton is the editorial director of Lab Manager. He spent 30 years as a research chemist, lab manager, and business leader at Air Products and Intertek. He earned...

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Plas-Labs, Inc. (Lansing, MI) has created a custom portable sampling isolator in cooperation with Hikma Pharmaceuticals (Columbus, OH). The new device builds on Plas-Labs’ history and experience constructing a wide variety of lab enclosures. Their modular construction process enables significant flexibility in design and purpose. 

This specific isolator has been designed to meet Hikma Pharmaceuticals’ needs for a portable loss on drying isolator to be deployed in different cleanroom spaces of their manufacturing facility. It has been built to meet a containment performance target of 0.1 µg/m3 using a surrogate powder that replicates production activities. 

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This device will enable manufacturing staff to safely produce pharmaceutical products without risk of inhaling or ingesting particles. While these medicines are important to those suffering from medical issues, it is important to eliminate contact with healthy employees.

To test the new custom device, Plas-Labs and Hikma Pharmaceuticals cooperated in an onsite test at Plas-Lab’s headquarters. The goal was to identify any performance issues before the device comes to the plant. Hikma Pharmaceutical sent a team of engineers and a mobile cleanroom to Lansing, MI and tested the isolator while monitoring performance and collecting air samples to trap any particles that escaped the test. Any particles captured in the filters of the air sampling will be analyzed for content and quantitated. The engineers will also test failure modes of the isolator and ensure that workers will be safe even if there is a catastrophic failure of different parts of the system. Cooperating on onsite testing enables quick repair or redesign of features and saves an estimated $20,000 – $65,000 in outsourced safety testing.

The value of this custom isolator to Hikma Pharmaceuticals is clear. Duane Smith, associate director of environmental, health, safety, and security says, “We must ensure employees are protected from pharmaceutical agents like oncology and anti-seizure medications.” Hikma Pharmaceutical greatly values building partnerships with important vendors. “The partnership with Plas-Labs is invaluable,” adds Smith. “These guys have found ways to make things more efficient and affordable.”

Plas-Labs has 55 years of experience manufacturing glove boxes and other enclosures. They feature in-house manufacturing and design, which allows them to be fast and flexible. Michael Regan, president of Plas-Labs, says, “Plas-Labs provides a cost-effective, turnkey design and build solution for all of your containment needs. This includes everything from the initial design review, to engineering and CAD modeling, to overseeing the manufacturing and testing of the finished product.” They strive for a straightforward approach to projects. “Keep things simple. We don’t want to over-engineer things,” adds Regan.

Providing rapid, affordable customized products is also an important part of their business. Regan says, “Partnerships are valuable. Each side gains knowledge from the other.”