Bio-Pharmaceutical Cleanrooms

Pharmaceutical cleanrooms in the United States fall under the oversight of the FDA, while in Europe they are regulated by the EMA. These pharmacy cleanrooms facilities must comply with CGMP standards. According to the FDA, GMP encompasses the Current Good Manufacturing Practice regulations that the agency enforces. Compliance with CGMP ensures the identity, strength, quality, and purity of drug products through adequate control of manufacturing operations by medication producers within a pharma clean room environment. In essence, GMP promotes consistent product quality and safety in pharmaceutical cleanroom settings by emphasizing five core elements, commonly known as the 5 P's: people, premises, processes, products, and procedures.

Wiskind modular cleanroom systems have been utilized by various pharmaceutical manufacturers for their CGMP FDA validation cleanrooms. In pharmaceutical cleanrooms, filling rooms generally require a class 100/ISO5 pharmaceutical clean room classification, whereas other areas in the pharmacy cleanroom or pharma clean room may operate at lower classifications based on their intended functions.

Key Components of Pharmaceutical Cleanrooms

Pharmaceutical cleanrooms typically incorporate several essential elements to ensure optimal performance and compliance. These include FRP modular walls designed for superior chemical resistance, room-side replaceable HEPA fan filter units for efficient air filtration, FRP ceiling tiles for durability and cleanliness, heat-welded vinyl floors featuring integral coves to facilitate easy maintenance, as well as interlocked material transfer and gown rooms to maintain controlled access. Additionally, precise temperature and humidity control systems are integrated to support stable environmental conditions.

Components Included in Wiskind Pharmaceutical Cleanroom Systems

Abbvie

Allergan

Baxter

Bausch and Lomb

Johnson & Johnson

Hardy Diagnostics

Hyacinth Protein

KC Pharmaceuticals

LGM Pharma

Midwest GMP

Nephron Pharmaceuticals

Regeneron Pharmaceuticals

Robinson Pharmaceuticals

Roche Diagnostics

Sparsha Pharma

Stemcell Bio

The design basis for a GMP (Good Manufacturing Practice) cleanroom in the field of biopharmaceuticals

1) "Guidelines for Good Manufacturing Practices for Pharmaceutical Products" (Revised in 1992) by the Ministry of Health.

2) "Design Specifications for Cleanrooms in the Pharmaceutical Industry" (1997).

3) "Implementation Guidelines for Pharmaceutical Production Management Standards" (1992).

4) "Design Specifications for Cleanrooms" (1984).

5) "Design Specifications for Ventilation and Air Conditioning" (GBJ19-87).

6) "Management Standards for Non-woven Medical Device Production" (YV/T-0033-90).

7) Technical documentation provided by owners, including process layout drawings, and other related materials.