Biopharmaceutical Laboratory Design and Equipment Needs Introduction to Biopharmaceutical Laboratories
2024.08.19
Biopharmaceutical Laboratory Design and Equipment Needs
Introduction to Biopharmaceutical Laboratories
The biopharmaceutical industry has advanced to a stage of standardization, modularization, and scaling. Constructing a biopharmaceutical laboratory requires strict adherence to relevant standards and regulations. Recent updates to GMP guidelines and national policies have heightened the requirements for biopharmaceutical facilities and laboratories.
I. Composition of Biopharmaceutical Laboratories
A biopharmaceutical laboratory typically comprises two main sections:
- Physicochemical Laboratory:
This section uses physical and chemical methods to analyze and test raw materials, intermediates, and finished products for identification and quantification.
- Microbiological Laboratory:
This section conducts essential functions such as validation of microbiological testing methods, sterility testing, microbial limit testing, antibiotic potency testing, and activity determination of penicillinase, as per the Chinese Pharmacopoeia. Compliance with GMP standards for cleanliness and other regulatory requirements is also necessary.
II. Design Layout of Biopharmaceutical Laboratories
Common laboratory layouts include:
- Single-Channel Linear Layout
- Double-Channel U-Shaped Layout
- Large Room with Small Rooms Layout
- Hybrid Layout
Each layout offers distinct advantages and should be selected based on the laboratory’s workflow and functional requirements.
III. Key Points in Biopharmaceutical Laboratory Construction
1. Material Selection:
Materials should be smooth, durable, low-dust, easy to clean, non-corrosive, and water-resistant. Recommended materials include glass, color steel plates, stainless steel combined with glass for walls, prefabricated color steel plates for ceilings, and seamless PVC flooring for the laboratory floor.
2. Construction Details:
- Use curved aluminum profiles for all joints between walls, floors, and ceilings to ensure sealed, cleanable connections.
- Glass, stainless steel, and prefabricated color steel plates should have curved edges where possible.
- Seal all gaps in lighting, sterilization, and gas supply pipelines with neutral silicone after ceiling installation.
3. Cleanroom Requirements:
According to the Chinese Pharmacopoeia, the environment of sterility testing rooms for sterile drugs and microbial limit testing rooms for non-sterile drugs must meet a cleanliness level of 10,000 (with localized cleanliness at level 100). The cleanroom construction must adhere to the Cleanroom Construction and Acceptance Code (GB50591-2010). This involves thorough cleaning and purging of pipelines and rooms for at least 12 hours before installing high-efficiency filters, which should be installed in one step without repeated disassembly.
These guidelines ensure that biopharmaceutical laboratories meet the necessary standards for effective and compliant operation.
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