Smoke study or air flow visualization is the important factor in clean room qualification. My query to some experts were as following 1. What will be the requalification frequency for Smoke study?2. If there is no significant changes in the clean room design is it require to do periodic evaluation of smoke study?3. Any Guidance […]
Recommendation Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This typically at a distance of 15-30 cm from the filter face. Rationale for Recommendation The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g, area where products , product contact packaging components, and product contact surfaces are exposed) is to ensure adequate airflow to protect […]
How to calculate conveyor speed in Tunnel? Dry heat is used for sterilization instead of the much more efficient moist heat because some materials are sensitive to moisture. Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material. The process of sterilization within a chamber or hot […]
Building Management System (BMS) is monitor and control the parameters of HVAC system like temperature, relative humidity and air quantity to maintain a controlled environment.
How are Disinfection Qualification Studies Regulated? The success of disinfection procedures used in an aseptic manufacturing environment and the qualification of such processes to complying with GMP’s are not detailed in a simple guidance document. Although there is no harmonized protocol addressing the regulatory requirements associated with disinfection qualification studies, there are several approaches, principles […]
Clean room practice is one of the toughest task in sterile pharmaceuticals. Now a days advanced HVAC system was designed to provide human comfort at working area and to maintain clean room requirement as per guidelines. Major regulatory guidelines now a days available with well define limits of viable and non viable for different grades (A,B,C,D). But […]
1. PW Generation, Storage and Distribution System2. WFI Generation, Storage and Distribution System3. PSG Generation and Distribution System
CFR – Code of Federal Regulations Title 21 [Code of Federal Regulations][Title 21, Volume 4][Revised as of April 1, 2013][CITE: 21CFR211] TITLE 21–FOOD AND DRUGSCHAPTER I–FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER C–DRUGS: GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Subpart J–Records and Reports Sec. 211.182 Equipment cleaning and use […]
There are different sizes and types of Air Handling Units. Some will fit in a closet or within a ceiling space, while others will require a mechanical room or will need to be placed on the roof of a building. Within all of them, however, there is at least one fan and one method of […]
Following qualification study to be perform during Installation qualification but not limited to · Training sheet (For keep the training attendance ) · Purchase order verification (To match with PO) · Drawing verification (To verify GA drawing, Electrical drawing etc.) · Document verification (To verify Installation manual, operation manual, test certificate etc) · Prestart review […]
