Equipment design is vital factor during cleaning and its validation, semi automatic or fully automatic clean in place systems are of important point of inspection by regulatory agencies, equipment with sanitary piping with out ball should be employed.
Whether the equipment requires special training of operators for cleaning operations, and cleaning these systems and its valves. The operator’s knowledge and training is also important. The written and documented cleaning process sop which should be properly validated for these equipments.
In case of large systems like long transfer or piping the proper flow chart for the operation should be in place with piping diagram with valves and written cleaning procedures. Valves and piping’s should be tagged and properly identifiable by operators during the operation and while cleaning as well.
Establishing proper time period between completion of a process and its each cleaning step is also important and are examined during inspection as critical points, as in case of suspensions and topical preparations the time period may be sufficient to allow drying of residue making it difficult to clean and the efficacy of the adapted cleaning procedure may be lost.
Microbial aspects of cleaning procedures and equipment are also equally important, after cleaning equipment should not allow microbial proliferation, there should be a proper standard operating procedure for cleaning and storage of equipment, after cleaning, never the less the cleaning procedure should be able to remove the all microbial contaminations if at all. good maufacturing practices
Dry equipments after cleaning before storage, stagnant water over any part or inside any part of equipment after cleaning is not allowed under any circumstances.
Sanitization and sterilization procedures should be adapted for equipments where ever necessary before using them for sterile manufacturing or for the process requiring higher degree of microbial control, equipment cleaning and sterilization are important factors in removing and inactivation of pyrogen.
Cleaning validation articles series:
Cleaning Validation Protocol
Residue of detergent after equipment cleaning, is there any limit for residue of detergent ?
LIMIT FOR RESIDUE AFTER CLEANING
Cleaning validation requirements
Sterile drug product validations
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures
What is pharmaceutical product information manual (Pharmaceutical product dossier) for registration of pharmaceutical product to foreign countries
Pharmaceutical Process Validation Series
Process Validation documentation.
Pharma process validation and concurrent release of PPQ batches
Process validation aspects of Analytical Methodology.
Process Validation Stage 3 The Continued Process Verification.
Process Validation : Process Qualification and Process Performance Qualification (PPQ)
Process Design and Process Validation Recommendations
Process validation and its regulatory, statutory requirements.
Process Validation and Drug Quality Approach to Process Validation.
General Considerations for Process Validation and Recommendations
Terms used in pharma validations and their definitions
Quality by design concept for pharmaceutical industry
Quality by design concept in pharmaceutical industry an explanation
Clean Room Classification
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