processing of cells and tissues - swiss cleanroom community...the most difficult production in...
TRANSCRIPT
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Processing of cells and tissues Jiri Hrubon
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CONTENTS
I. Introduction
II. Sterile production
III. Handling of cells and tissues
IV. Cell cultivation
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INTRODUCTION
• Company BLOCK has been found in 1991
in the Czech Republic
• Main activities are in pharmaceutical
industry, biotechnology, R&D,
microelectronics and health service
• Producer of clean rooms and equipment like
walls, doors, ceiling system, SS furniture
and isolators
• More than 450 employees in group
• Main target markets are CZ, SK, RU and
DACH
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Sterile production
The most difficult production in pharmaceutical industry
Production covered by clean rooms in required conditions with appropriate filtration
class in accordance with EN ISO 14644
Production preventing microbiological and particle contamination
Solutions for sterile production
1. Terminal sterilization (in final packaging)
2. Aseptic production (for whole or part of the production)
What is the sterile production?
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Sterile production
Production in dedicated cleanliness classes:
„A“ for filling process
„C“ for compounding, weighing, etc.
„D“ for material preparation or manipulation
People and material enter clean rooms via
material/personal airlocks
All clean rooms must be under control of:
particle measuring
microbiological monitoring
Big potential for isolator technology
Requirements
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Sterile production
Minimized microbiological contamination
Minimized personal innervation into the process
Aseptic processes covered by class „D“
One of the biggest risk of contamination is material
transfer into the isolator
Whole process validated before the start up
Tighteness class of the isolator in accordance with ISO
10648-2 and regularly checked
Regular tests also for glove‘s tightness
Isolator technology
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Handling of cells and tissues
Working with cells and tissues has increased in recent years
Biological material must be processed in sterile conditions
Material comes from:
genetically modified cells
tissues from donors
Used for biological kind of treatment
Main activities with those materials
cell removal
filtering
separation
centrifuging
cultivation
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Isolator technology for cells and tissues
Design is one the most important part of the sterile isolators
Required integration of supportive devices
Decontamination provided by VHP generators
Required positive pressure inside of the isolator‘s chambers for
product protection
Each chamber equipped with isokinetic probe for particle
measuring
Microbiological monitoring is required:
petri dish located in chamber
active microbiological monitoring with automatic system
Whole process validated and revalidated for future purpose
according to GMP rules
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Processing of human‘s materials
Class „A“ with laminar flow
Positive pressure
Sterilization by VHP generator
Isolator for tissues
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Isolator for cells
Processing of animal materials
Class „A“ with laminar flow
Positive pressure
Sterilization by VHP generator
Integrated steam sterilizer
Integrated CO2 incubator
Integrated centrifuge
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Isolator for cells
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THANK YOU
FOR YOUR ATTENTION