loading and unloading of lyophilizers - · pdf fileloading and unloading of lyophilizers ......
TRANSCRIPT
![Page 1: Loading and Unloading of Lyophilizers - · PDF fileLoading and Unloading of Lyophilizers ... • Installation of additional washer ... (SAT, IQ, OQ) by vendor • 4 weeks IQ, OQ, PQ](https://reader031.vdocuments.mx/reader031/viewer/2022021419/5ab4e34a7f8b9a156d8c4f1c/html5/thumbnails/1.jpg)
Loading and Unloading of Lyophilizers
Arnold Stoker
Project Manager
Sanquin’s approach to EudraLex Annex 1 Compliance
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• Introduction of Sanquin Blood Supply
• EudraLex Annex 1
• Articles 116 and 120
• Current Situation
• Design of Transport System
• Design Limitations
• Operation
• System Implementation
• Installation & Qualification planning
AGENDA
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Introduction of Sanquin Blood Supply
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• Sanquin Division Plasma Products
• Manufacturer of parenteral plasma products
• Sanquin products and CMO
• Partnership with CAF (Belgium) and LFB (France)
• Registrations in EU, US and ROW
Introduction of Sanquin Blood Supply
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• Article 116:
• Partially stoppered freeze drying vials should be maintained under Grade A
conditions at all times until the stopper is fully inserted.
• Article 120:
• 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
Articles 116 and 120
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EudraLex Annex 1
Current Situation
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Design of Transport System
![Page 8: Loading and Unloading of Lyophilizers - · PDF fileLoading and Unloading of Lyophilizers ... • Installation of additional washer ... (SAT, IQ, OQ) by vendor • 4 weeks IQ, OQ, PQ](https://reader031.vdocuments.mx/reader031/viewer/2022021419/5ab4e34a7f8b9a156d8c4f1c/html5/thumbnails/8.jpg)
• Two mayor design limitations:
• Space available
• …..
Design of the Transport System
Design limitations
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• Two mayor design limitations:
• Space available
• Lyophilizers of different age, size, manufacturers
Design of the Transport System
Design limitations
Christ, 1997
Klee, 2003
Klee, 2010Solution:
transport of product vials in frames
-Stable
-Frames needed
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Design of the Transport System
Operation
Chris, 1997
Klee, 2003
Klee, 010
OPTIMA 2013
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Design of the Transport System
Operation
Formatting
station
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Design of the Transport System
Operation Formatting
station
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Design of the Transport System
Operation
Transport to
lyophilizers
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Design of the Transport System
Operation Loading/Unloading
robots
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Design of the Transport System
Operation
Transport to
deformatting
station
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Design of the Transport System
Operation Transport to
deformatting
station
Deformatting
station
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Design of the Transport System
Operation
Deformatting
station
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Design of the Transport System
Operation
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• Total shutdown period: 14 weeks
• Impact on other systems:
• Changes in 44 of 46 rooms of fill finish department
• Installation of additional washer
• Replacement of autoclave
• Replacement of lyophilizer
• For the transport system:
• 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
System implementation
Installation and Qualification Planning