Cascade Airlock: These airlocks are very common having a higher pressure on one side and lower pressure on another side. This prevents to enter dust and contaminants from outside to airlock and from airlock to inner side. Bubble Airlock: These types of airlocks have a higher pressure inside the airlock ...

1. Introduction 2. Number of Intermediates and APIs batches produced. 3. Review of out put for all Isolated Intermediates and Finished Products. 4. Review of Critical Quality attributes of In-process, Isolated Intermediates and Finished Products. 5. Summary of changes made during the year with respect ...

Number of air changes/hour in an area is =Total Room Airflow in CFM x 60 / Total Volume of room in cubic feet ACH = CFMx60/Room Volume Example: Say the volume of the room is 1,200 cubic feet, and the volume of air the HVAC system is going to supply is 200 CFM. Thus, ACH = 200×60/1,200 = 10. This ...

Dynamic Pass Box is equipped with a suction HEPA filter of around 0.3 microns. A static pass box doesn’t have a filter. 1. Dynamic Pass Box: A dynamic pass box is equipped with HEPA/ULPA filters and operates with air circulation to prevent contamination during the transfer of materials between ...

An AHU plays a critical role in maintaining cleanroom conditions, controlling particulate contamination, and ensuring compliance with regulatory requirements (USFDA, EU GMP) 1. Air Intake and Pre-Filtration Fresh air Intake: The AHU draws in fresh air and passes it through pre-filters (10-micron filters) ...

User Requirement Specificatio (URS): Define the intended use of the instrument. List performance requirements, such as accuracy, precision, and operational range. Include compliance needs with GMP, GDP, or other regulatory guidelines. Design Qualification (DQ): Document that the design of the instrument ...

Air changes per hour (ACPH) Ref. Guideline: ISO 14644 Air changes in pharmaceutical cleanrooms play a significant role in maintaining the cleanroom quality as per ISO Cleanroom Classification through the HVAC system. Air change per hour is the number of total replacements of any room air in one hour. ...

In the pharmaceutical industry, the selection of flooring is critical to ensure compliance with regulatory standards like GMP and ISO 14644. Floors in cleanrooms, laboratories, and production areas must be durable, easy to clean, and resistant to chemical exposure. Epoxy Flooring Epoxy flooring is ...

API refers to the key ingredient or chemical that makes the drug work. While a finished formulation or a formulation intermediate is the process in which different chemicals including the active ingredients are mixed in specific ratios to produce a specific drug. API (Active Pharmaceutical Ingredient): The ...

Polyurethane is a versatile material that plays a significant role in the pharmaceutical industry, particularly in cleanroom environments, where stringent cleanliness and durability standards are required. Trolley Wheels: Used in cleanroom trolleys to transport materials safely without contaminating ...