How do you keep your GMP facility free of microbial contaminants?

Microbial contamination is a serious threat to the quality, safety, and efficacy of any product manufactured under Good Manufacturing Practice (GMP) standards. It can cause spoilage, degradation, infection, or adverse reactions in consumers or patients. To prevent or minimize the risk of microbial contamination, you need to follow strict cleaning and sanitation procedures in your GMP facility. Here are some tips on how to keep your GMP facility free of microbial contaminants.

1 Clean rooms and equipment

The first step to prevent microbial contamination is to ensure that your clean rooms and equipment are properly designed, maintained, and cleaned. Your clean rooms should have appropriate air filtration, ventilation, and pressure systems to prevent the entry of airborne microbes. Your equipment should be made of materials that are resistant to corrosion, abrasion, and microbial growth. You should also follow a regular cleaning schedule and use validated cleaning agents and methods to remove any dirt, dust, or residues that could harbor microbes.

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HARI SHANKAR PATEL

Bioprocess| Upstream| Downstream| cGMP manufacturing| Scaleup| Technology Transfer |Validation
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There are multiple ways to build and design a cleanroom facility that will meet GMP requirements for the sterile manufacturing of drugs. Here is a list of considerations keep in mind before elaborting on your design: -Flush Design and Finish. -Routine Environmental Monitoring, Control & Microbiological Monitoring -Airlocks and pass-throughs (PAL/MAL) -Interlocking System -At Rest vs. In Operation -HVAC System -Sinks and Drains -Doors

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2 Train and monitor staff

The second step to prevent microbial contamination is to train and monitor your staff on the best practices of GMP cleaning and sanitation. Your staff should be aware of the sources and routes of microbial contamination, such as raw materials, water, personnel, packaging, or cross-contamination. They should also follow the standard operating procedures (SOPs) for cleaning and sanitation, such as wearing appropriate protective clothing, washing hands, using disinfectants, and documenting their activities. You should also conduct regular audits and inspections to verify that your staff are complying with the GMP requirements and identify any gaps or issues.

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Shabana Chaudhry A.

Quality Assurance SME | Training, Compliance, Quality Systems Management, Remediation
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Dedicated equipment, Company supplied clothing, shoes, shoe covers, hair covers, gloves, masks, etc. “PPE” to protect the Product(s) and environment. Invest the money in quality supplies to prevent future issues. For example, gloves that save money but tear easily will force you to double up or likely contaminate something.

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3 Validate and verify processes

The third step to prevent microbial contamination is to validate and verify your cleaning and sanitation processes. Validation is the process of proving that your cleaning and sanitation methods are effective and consistent in removing or reducing microbial contaminants to acceptable levels. Verification is the process of confirming that your cleaning and sanitation methods are performed correctly and according to the validated parameters. You should use appropriate sampling and testing methods, such as swabs, rinses, or contact plates, to measure the microbial load on your surfaces and equipment. You should also establish acceptance criteria and corrective actions for any deviations or failures.

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4 Control and monitor water quality

The fourth step to prevent microbial contamination is to control and monitor your water quality. Water is a common source and vehicle of microbial contamination, especially if it is used for rinsing, mixing, or diluting your products or ingredients. You should ensure that your water supply is treated and purified to meet the specifications for the intended use, such as potable water, purified water, or water for injection. You should also monitor your water quality regularly for any microbial or chemical contaminants, such as bacteria, endotoxins, or heavy metals. You should also maintain your water distribution system to prevent biofilm formation, corrosion, or leakage.

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5 Manage and dispose waste

The fifth step to prevent microbial contamination is to manage and dispose your waste properly. Waste can be a potential source of microbial contamination, especially if it contains organic matter, liquids, or hazardous substances. You should segregate your waste according to the type and risk level, such as general waste, infectious waste, or chemical waste. You should also store your waste in closed and labeled containers and dispose it according to the local regulations and environmental standards. You should also clean and disinfect your waste containers and disposal areas to prevent any cross-contamination or odors.

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6 Review and improve practices

The sixth and final step to prevent microbial contamination is to review and improve your cleaning and sanitation practices. You should continuously monitor and evaluate your cleaning and sanitation performance and outcomes, such as microbial counts, product quality, customer feedback, or regulatory compliance. You should also identify and implement any opportunities for improvement, such as updating your SOPs, training your staff, or adopting new technologies or methods. You should also keep abreast of the latest trends and developments in GMP cleaning and sanitation and benchmark your practices against the best industry standards.

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7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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How do you keep your GMP facility free of microbial contaminants?

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1 Clean rooms and equipment

2 Train and monitor staff

3 Validate and verify processes

4 Control and monitor water quality

5 Manage and dispose waste

6 Review and improve practices

7 Here’s what else to consider

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