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IIR document

Certification of pharmaceutical cold rooms.

Number: pap. S2-P3

Author(s) : BONED M., CAVALIER G.

Summary

The thermal performances of temperature-controlled rooms and storage premises used for pharmaceutical products are essential to ensure the preservation of heat-sensitive products at temperatures of 2 to 8°C in the pharmacy. Good distribution practices as well as French Pharmacy Council (Ordre des Pharmaciens) recommendations request a regular on-site qualification of temperature controlled cold rooms. Two standards could in fact be used in France to map the temperature in climate chambers: NF X 15140 and ISO CEI 60068-3-11. If the equipment is generally qualified by the manufacturer in the production plant, on-site qualification is quite rare in pharmacies. Regular qualification of such equipment in service is also quite exceptional. This paper presents a field study of the thermal performances of pharmaceutical climate chambers in pharmacies based on temperature measurements. The results of measurements and qualification of cold rooms in different pharmacies give an overview of the situation. Finally, the paper proposes solutions making it possible to assess and certify, at a reasonable cost, the performances of in-service cold rooms in pharmacies.

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Pages: 8 p.

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Details

  • Original title: Certification of pharmaceutical cold rooms.
  • Record ID : 30007190
  • Languages: English
  • Subject: Regulation
  • Source: 2nd IIR International Conference on Sustainability and the Cold Chain. Proceedings: Paris, France, April 2-4, 2013.
  • Publication date: 2013/04/02

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