Cleaning Validation: Dirty Secrets, Clean facts

Cleaning Validation

Scientific Solutions “R” Us Team of professionals are educated on ALL the current rules and regulations from Regulatory authorities globally.

Regulatory agencies expect companies to establish and monitor ‘clean’ and ‘dirty’ hold times for manufacturing equipment as part of a cleaning validation program. If hold times are validated under properly defined and controlled conditions the requirement to monitor either or both hold times might not be necessary, resulting in savings of time and resources as well as potential regulatory exposure.

Scientific Solutions “R” Us team of professionals are equipped with over 20 years of dedicated experience to cleaning validation and providing fast and cost effective Solutions worldwide.

 

 

In its Guide to Inspection of Validation of Cleaning Processes, the FDA considers identifying and controlling the length of time between the end of processing and each cleaning step an often critical element of cleaning processes. The FDA also expects some evidence that routine cleaning and storage of equipment does not allow microbial proliferation. The EU wants to see the key elements of a validation program clearly defined and documented in a validation master plan

Health Canada looks for the interval between the end of production and the beginning of the cleaning procedures as well time frames and conditions for the storage of cleaned equipment that do not allow microbial proliferation. Finally, the PICS guideline looks for documentation of both dirty and clean hold times. The practice developed that for established hold times, routine documentation track the equipment hold times to assure ongoing compliance.

Scientific Solutions “R” Us team of professionals are equipped with over 20 years of dedicated experience to cleaning validation and providing fast and cost effective Solutions worldwide.

Scientific Solutions “R” Us goes above and beyond just training.  SS”R” Us is ready to support you in taking your Cleaning Validation Program to the next level ensuring compliance, Quality, and saving your company money.

Please take the first step and Enroll in our fun and interactive Cleaning Validation Training Workshop and “Leave Your Problems with Us”slide2

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