Source: https://www.scribd.com/document/50342816/Blow-Fill-Seal-BFS-Technology-Guidance
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BrowseInterestsBiography & MemoirBusiness & LeadershipFiction & LiteraturePolitics & EconomyHealth & WellnessSociety & CultureHappiness & Self-HelpMystery, Thriller & CrimeHistoryYoung AdultBrowse byBooksAudiobooksArticlesSheet MusicBrowse allUploadSign inJoinBlow-Fill-Seal (BFS) Technology GuidanceKenneth H. Muhvich, Ph.D. Principal Consultant Micro-Reliance LLC
Pharmaceutical BFSIOA
Formed as an interest group in 1989 Consisted of companies involved in advanced aseptic processing using B/F/S machines, as well as vendors Forum for idea exchange Overarching purpose was to identify & document best practices for operation of B/F/S machines
Published “Points to Consider for Pharmaceutical Blow-Fill-Seal Manufacturing Operations” in September of 1993 That document described B/F/S operations and provided more general information. as well
B/F/S DRAFT Guidance
“The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow/Fill/Seal Technology” Originally written by the Pharmaceutical Blow/Fill/Seal – International Operators Association (BFSIOA)
The purpose of the guidance is to… provide a description of current B/F/S operations and best practices accurately reflect B/F/S manufacturing on a global basis focus on issues that are specific to B/F/S technology & aseptic processing
Sterile pharmaceuticals Liquid medical devices Aseptically filled products filled only using B/F/S technology Terminally sterilized products
1 – Advantages of B/F/S Technology
Personnel are not normally present during aseptic filling Greatest potential source of microbial contamination removed Containers are formed immediately before filling and sealing.BFS Process Outline
Polymer granules are melted and extruded under high pressure to form a plastic tube or “parison” The container is formed in a cooled mold by blowing sterile air or via vacuum The container is then aseptically filled and sealed in a highly controlled environment A diagram of the process is provided in the DRAFT guidance
Part 5. exposure time to environment is markedly reduced
2 Container Design
An extensive list of characteristics to be considered when developing a product to be packaged in a polymeric container is provided Characteristics described include: thermal resistance. extractables. opacity.
. barrier requirements. etc.Part 5. absorption.1 – Challenges of B/F/S Technology
Potential for leakage of hydraulic or cooling system fluids Particulate generation Polymer contamination due to handling and storage High heat output may affect airflow patterns or cause condensate formation
Part 6.1. leachables. chemical reactivity.
light transmission. inserts]. and overwrapping.1.2 Container Design
Container development should include evaluation of the following criteria: shape. closure type.
Part 6.Part 6.3 .1. water vapour transmission rate. gas permeation characteristics.Polymer
Chemical properties – compatibility of resin and product Barrier properties Sterilization properties Processing characteristics
. frangibility. rigidity. dosage requirements [volume. delivery. labeling.
2. blowing & ballooning air. CIP/SIP of air and product pathways. deflashing system and leak detection
Part 6. utilities.2 – Control of Critical Zone Environment
Point of fill has traditionally been considered to be the critical zone in a B/F/S machine FDA Class 100 (ISO 5) EU “effective Grade A shower” Area between parison cutting and mould sealing should also be considered a critical area and should be protected by air of appropriate quality to prevent microbial contamination
. mould design. filling system design.B/F/S Equipment Design
Much more complex that traditional aseptic filling equipment B/F/S equipment-related items include: extruder performance. polymer feed system.
2.3 Air Shower
Localized ISO 5 conditions at the point of fill are provided via an air shower that is appropriately designed.Part 6. Sterilizing grade filter or HEPA Sterilization or sanitization of air shower surfaces Monitoring viable and non-viable particulates in critical zones
Other Considerations Described in the Guidance
Product pathway cleaning and sterilization Mould design Deflashing (cropping) systems Equipment Monitoring Container/Closure System Leak Detection
Rooms in the Aseptic Processing Area should meet ISO 14644 Standards Guidance recommends that the B/F/S machine should be located in an ISO 8 (operational)/ISO 7 (non-operational) clean room
Polymer Storage and Distribution
Designed to ensure that contamination does not occur Should require clear procedures for handling polymer beads supplied in bags or gaylords [bins] Handling of waste polymer should be designed to prevent cross contamination
Product/Process Validation Leak testing to ensure hermetic seal Wall thickness Container opening Container moulding Fill volume Line stoppages
Extrusion process – high temperature and pressure Bacterial endospore challenge Bacterial endotoxin challenge Knowledge of bioburden and endotoxin levels on incoming polymer Polymer flush volume required for batch changes
In-process Controls Start-up Procedures Interventions – into the filling room. into the filling machine or into the critical zone Environmental Monitoring
Sanitization of “Critical Surfaces” Equipment Cleaning Cooling Systems Extruder Control Maintenance
ease of opening and expulsion of contents
. because the operator may have to reach into a critical zone Polymer handling Training
Product contamination – low risk due to limited time of product exposure and by eliminating operator interventions during product filling Sources of contamination are described Other product quality attributes.Facility Operation
Gowning requirements – Grade A/B clothing should be worn. e.g..
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