Loading and Unloading of Lyophilizers

Loading and Unloading of Lyophilizers
Sanquin’s approach to EudraLex Annex 1 Compliance
Arnold Stoker
Project Manager
AGENDA
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Introduction of Sanquin Blood Supply
EudraLex Annex 1
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Design of Transport System
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Articles 116 and 120
Current Situation
Design Limitations
Operation
System Implementation
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Installation & Qualification planning
Introduction of Sanquin Blood Supply
Introduction of Sanquin Blood Supply
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Sanquin Division Plasma Products
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Manufacturer of parenteral plasma products
Sanquin products and CMO
Partnership with CAF (Belgium) and LFB (France)
Registrations in EU, US and ROW
EudraLex Annex 1
Articles 116 and 120
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Article 116:
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Partially stoppered freeze drying vials should be maintained under Grade A
conditions at all times until the stopper is fully inserted.
Article 120:
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Vial capping can be undertaken as an aseptic process using sterilized caps
or as a clean process outside the aseptic core. Where the latter is adopted,
vials should be protected by Grade A conditions up to the point of leaving
the aseptic processing area and thereafter vials should be protected with a
Grade A air supply until the cap has been crimped.
EudraLex Annex 1
Current Situation
Design of Transport System
Design of the Transport System
Design limitations
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Two mayor design limitations:
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Space available
…..
Design of the Transport System
Design limitations
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Two mayor design limitations:
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Space available
Lyophilizers of different age, size, manufacturers
Klee, 2003
Christ, 1997
Solution:
transport of product vials in frames
-Stable
-Frames needed
Klee, 2010
Design of the Transport System
Operation
Klee, 2003
OPTIMA 2013
Chris, 1997
Klee, 010
Design of the Transport System
Operation
Formatting
station
Design of the Transport System
Operation
Formatting
station
Design of the Transport System
Operation
Transport to
lyophilizers
Design of the Transport System
Operation
Loading/Unloading
robots
Design of the Transport System
Operation
Transport to
deformatting
station
Design of the Transport System
Operation
Deformatting
station
Transport to
deformatting
station
Design of the Transport System
Operation
Deformatting
station
Design of the Transport System
Operation
System implementation
Installation and Qualification Planning
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Total shutdown period: 14 weeks
Impact on other systems:
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Changes in 44 of 46 rooms of fill finish department
Installation of additional washer
Replacement of autoclave
Replacement of lyophilizer
For the transport system:
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4 weeks installation
4 weeks commissioning & qualification (SAT, IQ, OQ) by vendor
4 weeks IQ, OQ, PQ including smoke studies and media fills
Registration CBE-30