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 cleanroom 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 cleanroom 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 for superior chemical resistance

- Room-side replaceable HEPA fan filter units (FFUs) for efficient air filtration

- FRP ceiling tiles for durability and cleanliness

- Heat-welded vinyl flooring with integral coves to facilitate easy maintenance

- Interlocked material transfer and gown rooms to control personnel and material flow

- Precision temperature and humidity control systems to support stable environmental conditions

Representative Clients

Wiskind’s pharmaceutical cleanroom systems have been trusted by a wide range of industry leaders, including:

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

Design Basis for GMP Cleanrooms in Biopharmaceutical Facilities

The design of Wiskind‘s biopharmaceutical cleanrooms is based on national and industry standards for Good Manufacturing Practice (GMP) and cleanroom engineering. The following documents and specifications serve as key references:

1. Guidelines for Good Manufacturing Practices for Pharmaceutical Products (Ministry of Health, Revised 1992)

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 clients, including process layout drawings and related materials