controlled according to specifications and approved for 5.2.5 If applicable, limits for process temperatures should filling. be documented and in-process monitoring should include temperature measurement. 23. In the case of continuous processes as those mentioned in there should be adequate 5.2.6 Computer systems used in controlling or monitoring ‘Principle’, controls to ensure that the gas complies with processes should be validated. specifications. 5.2.7 For continuous processes, a definition of a batch 24. Cylinders, mobile cryogenic vessels and valves should should be documented and related to the analysis of the conform to appropriate technical specifications and any bulk gas. relevant requirements of the Marketing Authorisation. 5.2.8 Gas production should be continuously monitored for They should be dedicated to a single medicinal gas or to a quality and impurities. given mixture of medicinal gases. Cylinders should be colour-coded according to relevant standards. They 5.2.9 used for cooling during compression of air should preferably be fitted with minimum pressure should be monitored for microbiological quality when in retention valves with non-return mechanism in order to get contact with the medicinal gas. adequate protection against contamination. 5.2.10 All the transfer operations, including controls before 25. Cylinders, mobile cryogenic vessels and valves should transfers, of liquefied from primary storage should be be checked before first use in production, and should be in accordance with written procedures designed to avoid properly maintained. Where medical devices have gone any contamination. The transfer line should be equipped through a conformity assessment procedure , the with a non-return valve or any other suitable alternative. maintenance should address the medical device Particular attention should be paid to purge the flexible manufacturer’s instructions. connections and to coupling hoses and connectors. 26. Checks and maintenance operations should not affect 5.2.11 Deliveries of gas may be added to bulk storage tanks the quality and the safety of the medicinal product. The containing the same gas from previous deliveries. The used for the hydrostatic pressure testing carried out results of a sample must show that the quality of the on cylinders should be at least of drinking quality. delivered gas is acceptable. Such a sample could be taken 27. As part of the checks and maintenance operations, from cylinders should be subject to an internal visual inspection the delivered gas before the delivery is added; or before fitting the valve, to make sure they are not from the bulk tank after adding and mixing.
controlled according to specifications and approved for filling. 23. In the case of continuous processes as those mentioned in ‘Principle’, there should be adequate controls to ensure that the gas complies with specifications. 24. Cylinders, mobile cryogenic vessels and valves should conform to appropriate technical specifications and any relevant requirements of the Marketing Authorisation. They should be dedicated to a single medicinal gas or to a given mixture of medicinal gases. Cylinders should be colour-coded according to relevant standards. They should preferably be fitted with minimum pressure retention valves with non-return mechanism in order to get adequate protection against contamination. 25. Cylinders, mobile cryogenic vessels and valves should be checked before first use in production, and should be properly maintained. Where medical devices have gone through a conformity assessment procedure , the maintenance should address the medical device manufacturer’s instructions. 26. Checks and maintenance operations should not affect the quality and the safety of the medicinal product. The used for the hydrostatic pressure testing carried out on cylinders should be at least of drinking quality. 27. As part of the checks and maintenance operations, cylinders should be subject to an internal visual inspection before fitting the valve, to make sure they are not 5.2.5 If applicable, limits for process temperatures should be documented and in-process monitoring should include temperature measurement. 5.2.6 Computer systems used in controlling or monitoring processes should be validated. 5.2.7 For continuous processes, a definition of a batch should be documented and related to the analysis of the bulk gas. 5.2.8 Gas production should be continuously monitored for quality and impurities. 5.2.9 used for cooling during compression of air should be monitored for microbiological quality when in contact with the medicinal gas. 5.2.10 All the transfer operations, including controls before transfers, of liquefied from primary storage should be in accordance with written procedures designed to avoid any contamination. The transfer line should be equipped with a non-return valve or any other suitable alternative. Particular attention should be paid to purge the flexible connections and to coupling hoses and connectors. 5.2.11 Deliveries of gas may be added to bulk storage tanks containing the same gas from previous deliveries. The results of a sample must show that the quality of the delivered gas is acceptable. Such a sample could be taken from the delivered gas before the delivery is added; or from the bulk tank after adding and mixing.
consult-manuf-automatic-adoption-pics-130529-comparison.docx