3PC-037 Cleaning validation of solution production in a hospital pharmacy

BackgroundCleaning of technical equipment should remove residues of products and cleaning agents, as well as avoid microbial contamination.1 In hospital pharmacies multipurpose equipment is used for the manufacture of different pharmaceutical preparations. Suitable well-documented cleaning procedures are necessary to guarantee patient safety by avoiding cross-contamination of drugs.PurposeEffective cleaning procedures should be developed and validated for multipurpose and drug-contaminated equipment used in the solution production e.g. stirrers, tanks, tubes and filling systems. As a final result the contamination risk of all possible production lines could be assessed.Material and methodsFocusing on direct product contact our multipurpose equipment was grouped into nine critical and 11 uncritical systems. For seven of nine critical systems, a validated cleaning process did not exist and had to be developed. The validation covered the cleaning status immediately at the end of production (t0) and after a 24 hours’ dirty-hold time (t24). Naphazoline nitrate was defined as the worst case active component of our solutions portfolio. The analytical (1/1000 dose criteria) and microbiological residue limits were calculated.1 The HPLC method for the quantitative analysis of naphazoline nitrate was validated.2 Based on a risk assessment evaluating the potential of contamination, the number of validation runs for each unit of equipment was defined. The analytical and microbiological results were quantified for each system. To assess the whole process the residues of all production lines at t0 and t24 were summarised.ResultsAn effective cleaning procedure was evaluated for each system and validated at t0 and t24. Each unit of equipment and all possible production lines met the analytical residue limits at t0, and at t24 with the exception of the tubes. The microbiological requirements were fulfilled for the clean-room zones D and C.ConclusionThe tube surface consists of polytetrafluoroethylene and has to be cleaned immediately after the end of the production (t0). All other systems are almost completely made of stainless steel and can be cleaned until t24. The cleaning validation of the solution production was the first process in our hospital pharmacy which was completely validated including a dirty-hold time.References and/or Acknowledgements1. GMP-Guideline, Annex 15: Qualification and Validation.2. ICH-Guideline, Topic Q2(R1): Validation of Analytical Procedures.