Pharmaceutical cleanrooms are regulated by FDA in the United States and EMA in Europe. Pharmaceutical cleanrooms must meet CGMP. Per the FDA, GMP refers to the Current Good Manufacturing Practice regulations enforced by the FDA. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. To simplify this, GMP helps to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P's of GMP—people, premises, processes, products, and procedures.

American Cleanroom Systems modular cleanroom systems have been used by numerous pharmaceutical manufacturers for their CGMP FDA validation cleanrooms. Pharmaceutical filling rooms are typically class 100/ISO5. Other rooms can be lower classification depending on specific use.

exterior of 4 ft by 10 ft portable, pharmaceutical modular cleanroom, stainless steel, “yellow rolling base

interior of pharmaceutical cleanroom, six cleanroom air return walls, white FRP cleanroom cleanroom, heat welded cleanroom floor

interior ISO7 pharmaceutical cleanroom, storefront double cleanroom door, cleanroom flooring, cleanroom ceiling

Typical components for pharmaceutical cleanrooms may include:

FRP modular walls for chemical resistance
Room side replace HEPA fan filter units
FRP ceiling tiles
Heat-welded vinyl floors with integral cove
Interlocked material transfer and gown rooms
Temperature and humidity control

Easy modification, fast delivery and proven materials make American Cleanroom Systems modular systems a popular choice for pharmaceutical cleanrooms.

American Cleanroom Systems pharmaceutical cleanrooms customers include:

AbbVie
Allergan
Baxter
Bausch and Lomb
Johnson & Johnson
Hardy Diagnostics
KC Pharmaceuticals
LGM Pharma
Nephron Pharmaceuticals
Regeneron Pharmaceuticals
Robinson Pharmaceuticals
Roche Diagnostics
Sparsha Pharma
Stemcell Bio

FAQs About Pharmaceutical Cleanrooms

Q: What is a pharmaceutical cleanroom?

A: A pharmaceutical cleanroom is cleanroom used for manufacturing of pharmaceuticals products such as medicines. They are required by the FDA to ensure the safety and effectiveness of the medicines. Pharmaceutical cleanrooms typical must be sterile and have extremely demanding cleanliness requirements.

Q: What cleanroom classification are pharmaceutical cleanrooms?

A: Pharmaceutical cleanrooms typically are ISO-5/class 100 for aseptic filling and sterile processes. Less critical area are often ISO-6/class 1000 or ISO-7/class 10,000. The EU GMP Annex puts similar but slightly more stringent requirements.

Q: What is a CGMP pharmaceutical cleanroom?

A: The FDA mandated CGMP Current Good Manufacturing Practices for pharmaceutical manufacturers which is a higher standard than GMP Good Manufacturing Practices. This is a higher standard for pharmaceutical cleanrooms.

Q: What cleanroom flooring is most common for pharmaceutical cleanrooms?

A: Pharmaceutical cleanroom flooring must be chemical resistant, otherwise the aggressive cleaning agents used in pharmaceutical cleanrooms will damage the flooring. The cleanroom flooring minimize joints and cracks. Contamination can get stuck in these features which can cause bacterial growth. The most common pharmaceutical cleanroom floorings are heat-welded vinyl with integral cove or epoxy coating with urethane over coat.

Q: What cleanroom wall is most common for pharmaceutical cleanrooms?

A: Pharmaceutical cleanrooms are subject to harsh chemical cleaning of both flooring and walls. Fiber Reinforced Plastic (FRP) walls have good chemical resistance are a common choice.

Q: What kind of cleanroom testing is most common for pharmaceutical cleanroom?

A: Pharmaceutical cleanrooms require both viable and non-viable particle testing. The viable testing is done with settling plates. The non-viable testing is done with laser particle counters.

Q: What are USP797/800 cleanrooms?

A: USP797/800 pharmaceutical cleanrooms are used for compounding drugs at pharmacies. Recommendations come from the USP however final authority lies with state pharmacy licensing boards. USP797/800 pharmaceutical cleanrooms typically have ISO-8 gown rooms, ISO-7 compounding rooms, and ISO-5 benches/glove boxes.