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home > pmps > summer 2021 > minimising contamination in pharma cleanrooms cleanrooms are essential to reduce possible contaminations from outside, and this q&a runs through how to manage a safe facility.
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Pharmaceutical Manufacturing and Packing Sourcer

Minimising Contamination in Pharma Cleanrooms Cleanrooms are essential to reduce possible contaminations from outside, and this Q&A runs through how to manage a safe facility.

PMPS: What does a cleanroom team need to know in order to successfully carry out their duties in pharma?

Paul Harencak: The cleanroom operators, quality inspectors, and production supervision must be trained in GMP and efficient recordkeeping to ensure compliance to the codes. Examples include handwashing, tool cleaning, test equipment, proper PPE, material handling in the cleanroom to guard against dirt and debris, proper equipment maintenance, and safety protocols when operating cleanroom equipment. It is important that cleanrooms are equipped with their own in-room heating, ventilation, and air conditioning (HVAC) equipment to keep the facility at ambient conditions, double sinks for dedicated washing of hands in one sink and tools and cleaning supplies in the other, its own hot water system maintained at the proper code temperature, as well as lockers for employees’ PPE. A dedicated quality team can monitor and record all activities to ensure code compliance, while production teams prepare the necessary paperwork to detail their work.

Cleanrooms are notoriously tricky to manage. What difficulties do companies face when dealing with pharma products?

The challenge in operating a cleanroom is to ensure all employees are aware of the restrictions needed to maintain a safe cleanroom environment. To that end, it is imperative that access to the cleanroom is restricted to authorised personnel only. Should an outside contractor have to work inside the cleanroom, detailed protocols are in place to make sure the contractor observes all the rules and regulations. Once again, the production and quality managers are responsible to escort the ‘outsider’ into the room and maintain strict adherence to code.

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Paul Harencak is Vice President at LPS Industries, headquartered in Moonachie, New Jersey, US. Paul’s responsibilities include marketing, purchasing, and all technical services. Paul has an extensive background in coating and laminating for aerospace and electronics, owned a laminating manufacturing company, and consulted for small to large manufacturers in the chemical coatings industry, prior to LPS. He is a graduate of Rutgers University, US, and qualified in Biochemistry Sciences. Paul is active in various business and civic organisations sitting on a number of boards in the science, business, and academic fields.
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