After many years working for the world leading manufacture in cleaning validation swabs and after a long list of customers requests to provide a template which would provide them with the security that a set criteria of dimensions where adhered to when performing the swabbing cleaning validation tasks, our new product was born and it compliments the required process of using a consist method as part of your validation recovery studies.
Depending on the type of manufacturing facility validation may take place at multiple points of the manufacturing process and can be as much as 10 times daily.
Our swabbing template is to be used for each validation study, the lifespan of the PTFE template is dependent on your application but we suggest that they are replaced at regular intervals and this written into your SOP.
Cleaning Validation is primarily applicable to the cleaning of process manufacturing equipment in the pharmaceutical & medical device industries. To focus on cleaning validation is to monitor cleaned surfaces to determine if equipment is adequately cleaned from previous batch product production, when a drug or active ingredient (API) was used in the manufacturing process.
When equipment is inadequately cleaned risk of bacteria would potentially contaminate the manufactured product subsequently also the equipment used. This primarily covers product contact surfaces in the cleaned equipment. Cleaning validation is not performed only to satisfy regulatory authorities, the safety of life is the primary objective, and product contamination presents serious liability issues for any pharmaceutical manufacturer or medical device company, not to say life threatening consequences for recipients of contaminated products.
For more information please contact Metron NanoTech Ltd