£239.20

CRC Press Validating Medical Packaging

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Last 549 days • 549 data points (No recent data available)

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£253.72 £237.75 £241.23 £244.72 £248.20 £251.69 £255.17 09 June 2024 24 October 2024 10 March 2025 25 July 2025 09 December 2025

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105 days · current 321 days 44 days 79 days 0 80 161 241 321 £239 £250 £251 £254 Days at Price

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Most common price: £250 (321 days, 58.5%)

Price range: £239 - £254

Price levels: 4 different prices over 549 days

Description

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
27 September 2002
Listed Since
10 February 2007

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