Validating medical packaging. (©2003)

• Record Type: Book
• Further Information: Note: Ronald Pilchik.
• Other Names: Pilchik, Ronald
• Contents: INTRODUCTION; What is Validation?; ; PACKAGE DESIGN VALIDATION; Elements of Package Design; Package Design Issues; Validation Flow Chart; Simulation Criteria; Qualified Suppliers; Tables 1-6; ; PACKAGE PROCESS VALIDATION; Introduction; Process Validation: What is It?; IQ, OQ, PQ; Process Capability Studies; Example: XYZ Medical Device Corporation: Validation Protocol-Process Capability Study; ; PUTTING IT ALL TOGETHER: THE VALIDATION PROTOCOL; The Validation File; File Maintenance; Employing the Process; Example: Package Validation File; ; REGULATORY ACTIVITIES; Selected Case Studies; Packaging Non-Compliances; Industry Generated Support Documents; HACCP-Furthering the Need for Package Validation; Appendix 1 Operations Manual (impulse Sealer)
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2003
• Copyright Date: 2003
• Extent: 1 online resource (151 pages), illustrations
• Subjects: 681/.761; Medical instruments and apparatus -- Packaging -- Standards -- United States; Equipment and Supplies -- standards; Product Packaging -- standards; MEDICAL -- Allied Health Services -- Medical Technology; Medicinska instrument och apparater; Förpackningar -- standarder -- Förenta Staterna; Kvalitetskontroll; United States; Electronic books
• Languages: English
• ISBNs: 1566768071; 9781566768078; 9781420014945; 1420014943
• Notes: Note: Includes bibliographical references and index.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.