current Good Manufacturing Practices (cGMPs) contain both requirements and guidelines for manufacturing of food and drug products in a sanitary environment. The Food and Drug Administration (www.fda.gov) FDA Title 21 mandates that any building used to manufacture a drug, food, medical device, cosmetics or holding of such shall be maintained in a clean and sanitized condition.
There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.
After construction, anywhere from 4 to 9 cleaning and disinfecting steps are performed prior to the start of validation cleaning and monitoring.
All cleaning personnel performing cGMP cleaning read, write and understand English and all personnel are trained in this type of work and understand the aseptic process.
For viable particles, Microbial monitoring is an effective way to measure for molds, bacteria and yeasts on surfaces and air after cleaning. Contact Plates and Bio-Air Sampling units are used for sampling.
A meeting with the customer to define test locations and determine the validation study is the first step to using contamination mapping for developing a certified cleaning program.
In general, PROTOCLEAN and the customer will meet and set up a program to ensure product protection and high yields.
PROTOCLEAN has had such success with their cleaning systems they are confident in reporting that by performing a top-down clean, super-clean, construction clean, and/or triple clean, air particle counts will decrease any where from 2 to 10 times and microbial counts by 2 to 15 times.
In the scientific testing below PROTOCLEAN was hired to replace a competitor.