cleaning validation for blister packaging machines in an austrian pharmacy
Abstract objective our pharmacy works in good manufacturing practice in the field of multi-dose personal blister repackaging.
This requires verification of cleaning procedures for the blister machine based on our environmental features and investigation of the worst possible production scenarios.
Method visual cleaning: after the machine is cleaned, we check whether there is visible residue on the surface. Cross-
Contamination: After blister packaging using residues of highly polluting risk drugs, contaminated tablets were analyzed.
Key drugs in the machine are identified by their dust formation potential.
Placebo foam-
The residues of these key drugs were packaged and analyzed using mass spectrometry.
We evaluated the drug correlation of contamination in both analyses by dose criteria.
Effectiveness of the results: Comparing the production conditions and technical structure of the blister machine, the validity of the verification results of the whole setup is studied.
As a result, no residue on the machine is visible after cleaning.
No pollution was detected on fragile tablets.
In the placebo tablets of 80% analyses, 280 of the contamination was not measurable, or less than 1%
The limit is closed according to the dose standard, with a maximum value of 8. 5%.
The production volume and cleanliness of other machines are comparable.
Conclusion The cleaning of the blister machine was successfully verified: visual cleaning was achieved;
The pollution value is significantly lower than the cutting value
Exclusion of restrictions on related crossover
Contamination of packaging drugs.
The results proved to be effective for the entire site.
This study provides evidence for the safety and quality of blister repackaging and can be used as a reference for similar environments.
Objective our pharmacy works in good manufacturing practice in the field of multi-dose personal blister repackaging.
This requires verification of cleaning procedures for the blister machine based on our environmental features and investigation of the worst possible production scenarios.
Method visual cleaning: after the machine is cleaned, we check whether there is visible residue on the surface. Cross-
Contamination: After blister packaging using residues of highly polluting risk drugs, contaminated tablets were analyzed.
Key drugs in the machine are identified by their dust formation potential.
Placebo foam-
The residues of these key drugs were packaged and analyzed using mass spectrometry.
We evaluated the drug correlation of contamination in both analyses by dose criteria.
Effectiveness of the results: Comparing the production conditions and technical structure of the blister machine, the validity of the verification results of the whole setup is studied.
As a result, no residue on the machine is visible after cleaning.
No pollution was detected on fragile tablets.
In the placebo tablets of 80% analyses, 280 of the contamination was not measurable, or less than 1%
The limit is closed according to the dose standard, with a maximum value of 8. 5%.
The production volume and cleanliness of other machines are comparable.
Conclusion The cleaning of the blister machine was successfully verified: visual cleaning was achieved;
The pollution value is significantly lower than the cutting value
Exclusion of restrictions on related crossover
Contamination of packaging drugs.
The results proved to be effective for the entire site.
This study provides evidence for the safety and quality of blister repackaging and can be used as a reference for similar environments.