ntroduction and Construction Requirements for Biopharmaceutical Laboratories
2024.08.19
Introduction and Construction Requirements for Biopharmaceutical Laboratories
Introduction to Biopharmaceutical Laboratories
Biopharmaceuticals are drugs produced using biotechnological methods. A biopharmaceutical laboratory typically consists of two main sections: the physicochemical laboratory and the microbiological laboratory.
- Physicochemical Laboratory
: This laboratory uses physical and chemical methods to analyze and test raw materials, packaging materials, intermediates, and finished products for identification and content determination.
- Microbiological Laboratory
: Functions include validating microbiological testing methods as per the Chinese Pharmacopoeia, conducting sterility tests, microbial limit tests, antibiotic potency tests, penicillinase and its activity determination, and measuring the cleanliness of cleanrooms in pharmaceutical production according to current Good Manufacturing Practice (GMP) standards.
Key Points for Biopharmaceutical Laboratory Renovation
- Material Selection
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- Construction Techniques
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- Cleanliness Requirements
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Construction Requirements for Biopharmaceutical Laboratories
- Microbiological Laboratory Design
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- Quality Control Laboratory
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- Laboratory Design
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Relevant Standards for Biopharmaceutical Laboratory Construction
- Architectural Design Code for Scientific Laboratories (JGJ91-93)
- Quality Acceptance Standard for Ventilation and Air Conditioning Engineering (GB50243-2002)
- Architectural Technical Code for Biosafety Laboratories (GB50346-2011)
- General Requirements for Laboratory Biosafety (GB19489-2008)
- General Guidelines for Biosafety in Microbiological and Biomedical Laboratories (WS233-2002)
- Good Manufacturing Practice (GMP2010)
These guidelines provide a comprehensive overview of the introduction and construction requirements for biopharmaceutical laboratories. For more details, please feel free to contact me on WhatsApp at +86 133 1627 2505 or click the link below:
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