Establishing A Cleanroom that Meets Good Manufacturing Practice (GMP) Guidelines

One of the most impactful precautions researchers can take in avoiding contamination is establishing and maintaining a cleanroom that meets Good Manufacturing Practice (GMP) guidelines. GMP regulations apply to all phases of cell collection, processing, and storage.ⁱ

What is Cleanroom Classification?

A cleanroom is an environment where the concentration of airborne particles is controlled. Cleanrooms are maintained and utilized in a manner that minimizes the introduction, generation, and retention of particulates in the environment. All cleanrooms that meet FDA GMP guidelines are classified according to the cleanliness level of the air inside them.ⁱⁱ Meeting these guidelines is one of the most critical issues for laboratories adhering to GMP requirements. The International Organization for Standardization (ISO), a non-governmental body that promotes worldwide standards to ensure safe, reliable, and high-quality products, developed classifications associated with the levels of cleanroom certification. According to both USA and EU GMP guidelines, cleanroom classifications should be carried out according to ISO 14644-1. This ISO classification impacts every cleanroom user in the GMP community.

Who Needs an ISO-Certified Cleanroom?

Many laboratories and clinical facilities need cleanrooms for myriad reasons. Contaminants or particles in the air greatly impact the process of both testing and manufacturing. The creation of particles by certain laboratory equipment can lead to accelerated degradation, contamination, and total loss of biologically relevant material.ⁱⁱⁱ When manufacturing biological products, it’s imperative to acknowledge that any change during the manufacturing process, may alter product quality and efficacy.^iv Therefore, within GMP facilities, it is important to classify clean areas accurately. One of the first steps is implementing cleanroom certified furniture and equipment. GMP compliance can be achieved when consistent GMP-grade materials from well-characterized sources are utilized.

Cleanroom Certified Equipment

It is critical to maintain proper attire/gowning, furniture, and equipment to minimize the risk of introducing contaminants. Equipment not qualified for cleanroom settings can present hurdles in proper cleanroom maintenance. For example, uncertified tools and equipment with motors and other moving parts can introduce a reservoir of environmental particles. Some essential tools and equipment are also supplied with engines and other devices that have potential particles to shed.

To ensure that their equipment can be trusted as an essential tool for cleanroom applications, PHC Corporation of North America (PHCNA) has invested in the classification of selected cold storage and cell culture incubators. Equipment that meets GMP standards are ISO cleanroom classified by Occupational Safety and Health Administration (OSHA) approved testing laboratories.^v PHCNA understands that ISO cleanroom classified equipment is essential in achieving high quality, repeatable results that meet cleanroom and GMP standards. PHCNA offers a full product line that represents more than 50 years of innovation throughout the life science community.

ⁱ Ottria G, Dallera M, Aresu O, Manniello MA, Parodi B, Spagnolo AM, and Cristina ML. “Environmental monitoring programme in the cell
therapy facility of a research centre: preliminary investigation.” Journal of Preventive Medicine and Hygiene 51, no. 4 (Dec 2010):133-8. PMID: 21553557

ⁱⁱ “Current Good Manufacturing Practice (CGMP) Regulations.” U.S. Food & Drug Administration (FDA), last modified 09/21/2020. www.fda.gov/
drugs/pharmaceutical-quality-resources/current-good-manufacturingpractice-cgmp-regulations

ⁱⁱⁱ Fernando Cobo, David Grela, and Ángel Concha. “Airborne particle monitoring in clean room environments for stem cell cultures.”
Biotechnology Journal, 3, no. 1 (January 2008): 43-52. doi.org/10.1002/biot.200700122 PMID: 18034434

^iv Moutsatsou, P., Ochs, J., Schmitt, R.H. et al. “Automation in cell and gene therapy manufacturing: from past to future.”
Biotechnology Letters, 41 (September 2019): 1245–1253 doi.org/10.1007/s10529-019-02732-z PMID: 31541330

^v OSHA maintains a list of approved testing laboratories that are recognized as meeting the standards and requirements necessary to
test and certify products for cleanroom standards. “OSHA’s Nationally Recognized Testing Laboratory (NRTL) Program - Current List of NRTLs.”
United States Department of Labor, Occupational Safety and Health Administration (OSHA).
www.osha.gov/nationally-recognized-testinglaboratory-program/current-list-of-nrtl