Injectable products like ophthalmic solutions, vaccines and injectable drugs are manufactured in sterile cleanroom areas. Cleanroom area must be free from visible particulate matter and microorganisms. Therefore, the cleaning and sanitization of cleaning room area is not just a routine task but it is also a critical component of contamination control and regulatory requirements.
In this blog post we will understand the procedures and best practices for cleaning sterile pharmaceutical manufacturing areas. We will also focus on regulatory compliance and product safety during sterile product manufacturing.
If cleaning in cleanroom area is not done properly then it can result in product contamination. When cleaning issues are observed in regulatory audits, it can lead to FDA form 483 and warning letters. So always try to follow the validated cleaning procedure to ensure regulatory compliance.
ISO 5 or Class A: Areas like Laminar Airflow hoods and other areas where sterile products are exposed categorized as ISO5 or grade A. They are the cleanest areas in sterile pharmaceutical manufacturing.
ISO 6 or Class B: These are the background or surrounding areas of grade A. These are less clean than grade A areas.
ISO 7/8 or Class C/D: These are less critical areas like change rooms or product preparation areas. The product is not exposed in this type of area.
Each grade of classified area requires a specific cleaning frequency to maintain it. Disinfectant rotation and cleaning methods play an important role in maintenance of clean room grade.
1. Cleaning Direction: Cleaning direction plays a major role in the contamination control. Always clean area from grade A to grade D. During equipment or wall cleaning, always clean from top to bottom to avoid redistribution of particles.
2. Mop and Wipe Technique: Always keep strokes unidirectional and with minimal overlapping. Avoid circular motions and change wipes and mops heads frequently to prevent contamination spread.
3. Contact Time:Floor must be wet with the disinfectant for the validated contact time (generally 5-10 minutes) to work effectively. After the contact time elapse mop the surface to dry.
4. Documentation: A detailed cleaning log must be maintained with date and time, area cleaned, name of operator, disinfectant and equipment used for cleaning. A record of cleaning must be signed and reviewed by quality assurance personnel.
Cleaning of pharmaceutical area important part of contamination control. It should be done properly and thoroughly with appropriate disinfectants and cleaning procedures. Training of employees working in cleanroom area and responsible for cleaning should have awareness about the essential steps for contamination control. Training has an important role to aware the staff and reduce contamination risks. If you have any issues with contamination control strategy in your sterile area, feel free to contact us for help.
In this blog post we will understand the procedures and best practices for cleaning sterile pharmaceutical manufacturing areas. We will also focus on regulatory compliance and product safety during sterile product manufacturing.
Why Is Cleaning in Sterile Areas So Critical?
According to cleanliness, the sterile area is classified in different classes from class A to class D. Sterile product manufacturing in cleanroom areas prevents contamination of particulate matter and microbes in injectable products. According to ISO 14644 and other regulatory guidelines, different classes have their acceptance limits for particulate and microbial counts.If cleaning in cleanroom area is not done properly then it can result in product contamination. When cleaning issues are observed in regulatory audits, it can lead to FDA form 483 and warning letters. So always try to follow the validated cleaning procedure to ensure regulatory compliance.
Classification of Cleanroom Areas
Cleanroom areas are classified based on airborne particles and microbial count. The cleanroom areas in pharmaceuticals are classified asISO 5 or Class A: Areas like Laminar Airflow hoods and other areas where sterile products are exposed categorized as ISO5 or grade A. They are the cleanest areas in sterile pharmaceutical manufacturing.
ISO 6 or Class B: These are the background or surrounding areas of grade A. These are less clean than grade A areas.
ISO 7/8 or Class C/D: These are less critical areas like change rooms or product preparation areas. The product is not exposed in this type of area.
Types of Cleaning in Sterile Areas
Cleaning in a sterile manufacturing area is divided into following types.1. Routine Cleaning
Routine cleaning is done after each working shift and visible dust and product residues are removed. This type of cleaning is applied to floors, walls, ceilings, doors and equipment in the cleanroom area.2. Disinfection
Disinfection helps to remove microorganisms present on the surface of the sterile area. It follows routine cleaning of the floor and equipment surface. Disinfectants used for cleaning should be rotated periodically to prevent microbial resistance.3. Deep Cleaning
Deep cleaning is done on a weekly basis and includes hard to clean areas and equipment. This includes fumigation of area grade A and B areas with a disinfectant like hydrogen peroxide solution.4. Cleaning After Maintenance or Incidents
After an incident or maintenance work, areas must be thoroughly cleaned to remove the contaminants. This also includes revalidation of area before restarting the production.Essential Components of an Effective Cleaning Program
A perfect cleaning program in sterile manufacturing includes following key components.1. Use Validated Cleaning Procedures
Cleaning procedures used for cleaning sterile areas must be validated and should demonstrate their effectiveness. Disinfectant validation should ensure the capability of cleaning method to remove residues and microbial contaminants.2. Trained Personnel
The house-keeping personnel responsible for cleaning the sterile area should be trained and qualified in cleaning. This training must include gowning procedure, cleaning techniques, disinfectant solution preparation procedure and contamination control techniques.3. Cleaning Agents
Approved disinfectants must be used that have good efficiency against bacteria, fungi and spores. Common disinfectants used in sterile areas are isopropyl alcohol (IPA), hydrogen peroxide (H2O2) and sporicides like peracetic acid.4. Disinfectant Rotation
Rotate at least three different disinfectants including a sporicidal agent to prevent microbial resistance and maintain effectiveness of the cleaning procedure. Disinfectants should be selected from different categories having different mode of actions.5. Dedicated Cleaning Equipment
Equipment used for cleaning a sterile area must be dedicated to sterile area only. Mops, wipes and buckets should not be used for other areas, and all cleaning equipment must be washed properly after each use.Cleaning Techniques and Best Practices
The cleaning techniques used in cleaning are very important because poor cleaning techniques can spread contaminants rather than controlling them.1. Cleaning Direction: Cleaning direction plays a major role in the contamination control. Always clean area from grade A to grade D. During equipment or wall cleaning, always clean from top to bottom to avoid redistribution of particles.
2. Mop and Wipe Technique: Always keep strokes unidirectional and with minimal overlapping. Avoid circular motions and change wipes and mops heads frequently to prevent contamination spread.
3. Contact Time:Floor must be wet with the disinfectant for the validated contact time (generally 5-10 minutes) to work effectively. After the contact time elapse mop the surface to dry.
4. Documentation: A detailed cleaning log must be maintained with date and time, area cleaned, name of operator, disinfectant and equipment used for cleaning. A record of cleaning must be signed and reviewed by quality assurance personnel.
Environmental Monitoring and Cleaning Effectiveness
Environmental monitoring is essential to verify the effectiveness of cleaning activities. Environmental monitoring includes settle plate, contact plate, swab testing and air sampling. Trending of environmental monitoring results must be done to identify the hot spots and cleaning process failures. It also helps to identify if results exceed alert and action limits and any requirement of investigation and corrective actions.Cleaning Frequency Based on Area Classification
Common Mistakes to Avoid
- Use of expired or unvalidated disinfectants
- Inadequate rotation of disinfectants
- Reusing dirty mops or clothes
- Skipping hard to reach areas
- Incomplete documentation or missing signatures
- Allowing untrained staff to clean critical areas
Regulatory Expectations and Guidelines
Cleaning in sterile areas must follow these regulatory guidelines.- FDA 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
- EU GMP Annex 1: Manufactureing of Sterile Medicinal Products
- WHO GMP Guidelines
- PIC/S Guidelines
Cleaning of pharmaceutical area important part of contamination control. It should be done properly and thoroughly with appropriate disinfectants and cleaning procedures. Training of employees working in cleanroom area and responsible for cleaning should have awareness about the essential steps for contamination control. Training has an important role to aware the staff and reduce contamination risks. If you have any issues with contamination control strategy in your sterile area, feel free to contact us for help.
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