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New Technical Monograph on Bio-contamination from PHSS

Posted by Rapid Micro Biosystems on November 26, 2014

new technical monograph on bio-contaminationContamination control is a vital part of producing safe, effective and sterile pharmaceuticals. Previously, we provided an overview of the PHSS Technical Monograph #20 “Bio-contamination characterization, control, monitoring and deviation management in controlled/GMP classified areas,” which offers guidance to pharma managers developing plans to minimize contamination in their operations. This week, we’ll delve further into the paper and discuss additional details.

The document details control strategies that include manufacturing, quality and contamination control and stresses that they’re interconnected and a robust strategy should blend all three, considering both facility design and daily operations. The control strategies are focused on, “product quality, efficacy, and patient safety.” 

Manufacturing Control

The document points out that manufacturing control strategies must be tailored to the main characteristics of the product and process, such as the product type and dose form, as well as the manufacturing processing method. Automation and equipment to be used is also part of manufacturing control, specifically the level of automation and how users will interact with the process. Risk assessment is a critical aspect to manufacturing control. 

Quality Control

As with the manufacturing control strategy, the document notes that quality control must be tailored to the process specifics, such as product, process and critical quality attributes (CQAs) in manufacturing. The document notes that quality control strategies are not to be designed to support bad designs or practices, and that there is a need for an approach that it methodical. As with manufacturing control, product quality, efficacy and patient safety are paramount. 

Contamination Control

The document notes that, “A Contamination control strategy should include a strategy for environmental control of product manufacturing environments...” It goes on to point out that contamination control strategies will vary based on the manufacturing process. 

The document goes into deeper details of considerations for setting a contamination control strategy, focusing on a “holistic view” of the following: 

  • Process, infrastructure, operations, components including raw materials
  • Microbial control strategy
  • Risk Management of Contamination (RMC)
  • Cross Contamination control/ containment strategy

Once these have been established with appropriate justification, the document explains that management must identify and assess areas of contamination risk. The risk management stage may be one of the toughest, but it’s necessary. Because contamination in Grade A and B areas likely originates from contamination in less controlled Grade C and D areas, the document observes that a successful control strategy should identify and mitigate risks associated with the perimeter of the facility and the flow of raw materials, equipment and personnel into the processing area. 

The PHSS monograph serves as a guide to designing an effective control strategy in the manufacture of sterile pharmaceutical/drug products. To document is available for purchase at the Pharmaceutical & Healthcare Sciences Society website

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