Pharmaceutical manufacture bioburden

Industry Perspective on Microbial Bioburden Control for Nonsterile Pharmaceutical Manufacturing... 

INDUSTRY PERSPECTIVE ON MICROBIAL BIOBURDEN CONTROL FOR NONSTERILE PHARMACEUTICAL MANUFACTURING... 

The natural bioburden in a well-maintained pharmaceutical parenteral manufacturing plant is quite low, often to the point that it is difficult to isolate and propagate plant bioburden for sterilization studies. Nevertheless, it is still important to characterize the microbiological bioburden in the process and then monitor it at regular intervals. 

As with traditional aseptic filling, in order to comply with pharmaceutical GMP, it is important to minimize contamination at all stages of manufacture. Raw materials should be of a high quality and tested for microbial contamination. Water used for product manufacture should be of low bioburden and high purity (preferably water-for-injection quality, although this requirement is dependent upon the nature of the product being manufactured). 

To establish a microbial-limit testing history, all development, clinical, scale-up and process validation batches of new nonsterile dosage forms would be tested to verify that the pharmaceutical ingredients, manufacturing process, and packaging does not contribute to the bioburden of the product. After the testing history has been... 

This document contains information related to the liquid aseptic fill operation used in the manufacture of (product name), USP, at ABC Pharmaceutical Industries located at (provide postal address). Additional information to support the liquid aseptic filling validation includes but is not limited to environmental monitoring and controls, as well as product-specific testing such as bioburden and sterility testing. The main subsections are ... 

ABC Pharmaceutical Industries routinely monitors the microbial content of the air, inanimate surfaces, personnel, water systems, and product component bioburden. Microbiological monitoring of these areas generally reflects on the efficiency of cleaning and sanitization procedures and employee practices. Continuous environmental monitoring provides the assurance that product is produced by a controlled process that will maximize the sterility and quality of the manufactured sterile product. 

Excipients Council (IPEC) [10] (excipients), and the USP [11] have also published GMP guidelines. These guidelines require manufacture of pharmaceutical products with acceptable microbial bioburden and free of objectionable microorganisms. 

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