The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology. K. Downey

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СКАЧАТЬ 7.1 Process Operation 46

       7.1.1 In-process controls 46

       7.1.2 Start-up procedures 47

       7.1.3 Interventions 47

       7.1.4 Environmental monitoring 48

       7.2 Equipment Operation 51

       7.2.1 Sanitisation of “critical” surfaces 51

       7.2.2 Equipment cleaning 51

       7.2.3 Cooling systems 51

       7.2.4 Extruder control 51

       7.2.5 Maintenance 52

       7.3 Facility Operation 52

       7.3.1 Gowning 52

       7.3.2 Polymer handling 53

       7.3.3 Use of regrind polymer material 53

       7.3.4 Training 53

       8. RISK ASSESSMENT 55

       8.1 Product contamination 55

       8.2 Other product quality attributes 57

       APPENDIX 59

       GLOSSARY 60

       GUIDANCE REFERENCES 62

       GENERAL REFERENCES 63

Disclaimer

      This document was produced and is disseminated by the Pharmaceutical Blow-Fill-Seal International Operators Association (the “Association”) as a service of the Association solely for the convenience of its members. These ‘Points to Consider’ are an effort to provide a compilation of current Blow-Fill-Seal (“BFS”) manufacturing operations and practices. In producing this document, the Association has attempted to reflect accurately the current state of BFS manufacturing operations on a worldwide basis. However, the Association makes no claim whatsoever regarding these ‘Points to Consider’ to any user of these ‘Points to Consider’, including without limitation, any claim that the document:

      – contains no errors

      – covers all actual or potential aspects of BFS operations

      – is in all instances completely up to date in its description or outline of current practice

      – represent the unanimous [or consensus] opinion of the BFS industry or the Association members

      – reflects the requirements of all applicable laws

      All use of these ‘Points to Consider’ shall be at the user’s sole risk.

      This document, and the procedures contained in the ‘Points to Consider’, has not been reviewed by, nor have they been endorsed by, filed or registered with, any governmental agency having jurisdiction over these matters. This document do not create any rights for, or confer any rights upon, any person, nor do they operate to bind the international and national authorities (FDA, European Commission, any other federal, state or local regulatory agency), or the public, in any manner. Where these ‘Points to Consider’ reiterate a requirement imposed by statute or regulation, the requirement’s having the force and effect of law is not changed or affected in any way by virtue of its inclusion in this document, nor does such inclusion give these ‘Points to Consider’ the force of law.

      The mention in this document of commercial products, their sources, or their use in connection with matters described in the ‘Points to Consider’ is not, and is not to be construed as, either an actual or implied endorsement of such products by the Association.

      The Association shall not be liable for, and disclaims all liability for, any and all losses, costs or damages, however arising, whether direct or indirect, incidental, consequential, punitive or exemplary, incurred as a result of or in connection with any person’s following, or failing to follow, these ‘Points to Consider’.

      The BFS process is a technical one and appropriate and adequately trained expert personnel must be employed at each stage of the BFS process.

1. INTRODUCTION

      Blow-Fill-Seal (BFS) technology has been used for pharmaceutical and liquid medical device manufacturing since the 1970s. This processing technology has become accepted worldwide for both aseptic and terminally sterilised liquid products and is currently used in more than 50 countries throughout the world.

      BFS technology lacks harmonisation and specific standards on a worldwide basis. As a result, the technology has developed in an isolated fashion, with each company and each regulatory agency establishing its own interpretation of acceptable BFS practice.

      In 1989, the Pharmaceutical Blow-Fill-Seal International Operators Association (BFS IOA) was established as an interest group of pharmaceutical and associated companies actively involved with BFS processing. The Association was formed to provide its members with an opportunity to exchange ideas and opinions, and to formulate agreement on operating standards. It also provides a forum to speak with a unified voice to machine manufacturers, commercial suppliers, and regulatory bodies. The Association has expanded worldwide and now has over 60 member companies.

      In an attempt to establish a common understanding of acceptable practice in BFS processing, the Association first published a “Points to Consider for Pharmaceutical Blow-Fill-Seal Manufacturing Operations” (PTC) document in September 1993. The document addressed points specific to BFS processing but also covered many more general areas. The current PTC document focuses on issues specific or unique to BFS technology and has undergone periodic review and systematic updates since its inception.

      This document is the culmination of several reviews during 2010 and 2011 and the most current version is from March 2012.

      The document is structured into 3 main sections covering design, start-up/validation, and routine operation. Within each section, Product, Equipment and Facility are considered.

	Design	Initial ­start-up	Routine ­operation
Product
Equipment
Facility

2. OBJECTIVE

      The objective of the ‘Points to Consider’ document is to provide recommendations specific to the operation of Blow-Fill-Seal technology СКАЧАТЬ