Pharmaceutical Guidelines

Checklist for Audit in Sterile Area Checklist to verify the sterile manufacturing area before the audit. 1. Is there any SOP giving details for activity/ movement in the sterile area. 2. Verify the suitability of system for sanitization of hands. 3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available? 4. Verify the availability of following records:  Air pressure differential  Particulate monitoring  Temperature  Humidity  Microbiological monitoring by settle plate 5. Are these records available and maintained as per SOPs? 6. Check the above mentioned individual records. Are the entries within specifications mentioned in SOP/ MTPs. 7. Is the controlled copy of MTP pertaining to monitoring by settle plate available to plant person? 8. Are the location for settle plates identified and the chart/ layout available with plant? 9. Are the following areas monitored for parameters mentioned in step 4:  Air-lock to the critical ar...

Cellulose Membrane Filters Used in Pharmaceuticals Different types of cellulose membrane filters used in pharmaceutical industries in microbial analysis and water systems. Membrane filters are thin polymer films those have many microscopic pores. These filters have different pores sizes and used for different purposes accordingly. Membrane filters are used in various pharmaceutical activities. Cellulose filters are most commonly used filters in  microbial analysis   and  reverse osmosis   water systems. Most of the cellulose membrane filters are hydrophobic in nature. Cellulose membrane filters are made of different cellulose molecules. But following two types of cellulose filters are used in pharmaceutical industries. 1. Cellulose Nitrate Membrane Filters:  Cellulose nitrate membrane filters (also known as nitrocellulose membrane filters) are prepared by the reaction of cellulose and nitric acid. Each glucose molecule in cellulose nitrate polymer is esterified ...

Buffer Area and Its Maintenance in Sterile Facility Know about the buffer area used for compounding of sterile pharmaceutical preparations and its maintenance for air quality as per ISO. The buffer area is the sterile zones in pharmaceutical manufacturing. Generally compounding area in  sterile pharmaceutical preparation   facility is known as the buffer area. The buffer area is always ISO 7 area (class 10,000) or better air quality. Buffer areas always contain positive pressure to avoid the entrance of particle and microbial contaminants and  differential pressure   should be maintained between 10-20 pascals.  HVAC system   helps to maintain the pressure and the air quality of the area. Buffer area should be surrounded by ISO 7 (class 10,000) or ISO 8 (class 1,00,000) area. According to USP 〈797〉 Pharmaceutical Compounding—  Sterile Preparations , unwanted objects (computers, printers, carts, cabinets etc.) that are not essential for compounding, cann...