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Loading and Unloading of Lyophilizers
Arnold Stoker
Project Manager
Sanquin’s approach to EudraLex Annex 1 Compliance
• 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
Introduction of Sanquin Blood Supply
• 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
• 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
EudraLex Annex 1
Current Situation
Design of Transport System
• Two mayor design limitations:
• Space available
• …..
Design of the Transport System
Design limitations
• 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
Design of the Transport System
Operation
Chris, 1997
Klee, 2003
Klee, 010
OPTIMA 2013
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 Transport to
deformatting
station
Deformatting
station
Design of the Transport System
Operation
Deformatting
station
Design of the Transport System
Operation
• 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