10 Things to Consider When Buying an In-Situ Sterilizable Bioreactor
(PresseBox) - The move from bench-scale bioreactors to larger units is a major step.making a buying decision.
1. Does
What working volume do you need for each batch and, having decided this, where can a unit of the right size be installed?
Cooling water
A low drain with heat-resistant pipework, that must also meet local municipal standards
Electrical supply (both single and three phases are often needed)
Oil-free, dry air and other gasses as needed (piped or bottled)
Clean, dry steam (a steam generator
Process water (for
Don?t forget to check that room has been allocated for peripheral equipment e.g. pumps, centrifuges or analysers to be used with the bioreactor.
2. How is your order processed?
A User Requirement Specification (URS) should be
The URS will be analysed by specialists in different departments, to ensure each item is considered and a suitable response given in reply or as part of a formal quote. The responsibilities
? Technical Support Construction (responsible for mechanical clarification and sequences)
? Technical Support Automation (responsible for the clarification of parameters, I/O list
? Quality
? Software (responsible for the requirements of control, recording, monitoring)
The reply to the URS will normally be a point?by?point confirmation. Any differences will be
Check the quotations carefully and make sure you compare ?apples with apples?. Just because something
3. Can
A unit which has used up
4. How automated are the sterilization, cleaning and operating processes?
Automation of these processes is a critical factor and should especially
Furthermore, for cleaning in place procedures,
Lastly, safe operation for both operators and product are paramount. How the system behaves when, for example, steam pressure is lost should be examined.
5.
The traditional way of doing this is to use silicone septa in ports on the top plate and pierce them aseptically using a large needle. This still may be useful for some actions, such as addition of inoculum or small volumes of supplement.
A push valve
For feeds and liquids which must be used quickly, a sterile
The key difference is that push valves are true extras and can be added to existing top plate ports as needed. A sterile cross is usually hard-piped, and of course, requires steam.
6. Is
The operator interface, both local and remote, should be easily accessible for new users and familiar.
7. How
Larger units have an ?open frame? design as standard. This provides full access to valves, pumps, heat exchangers gas pipework and the motor. This is a real benefit for complex designs with many sterile crosses and extra pipework.
8.
A larger vessel means larger impellors and the drive motor must be powerful enough to move them through the medium at a reasonable speed. The good news is that impellor tip speed can be used as a scale up criterion, and the stirrer speed can be lower as the impellor diameter is larger.
For larger vessels, even a microbial motor can be bottom mounted. When this is possible, other refinements become possible:
A water-cooled motor for operation at higher speeds as the cooling is far more efficient than with air.
Where vertical space is tight, a powerful magnetic drive can be used in place of a single or double mechanical seal.
9.
Smaller vessels canedium (which is heated under pressure to generate the steam) can be several hours. If house steam is unavailable, using a steam generator mounted on the vessel frame will be more efficient. In this case, using electrical heating for operation makes the most sense, so the steam generator is not in permanent use. Cooling often uses direct injection of cold water into the vessel jacket.
For larger
10.
If working under GMP conditions, validation and qualification is
Design Qualification (DQ)
Factory Acceptance Testing (FAT)
Installation Qualification (IQ)
Site Acceptance Testing (SAT)
Operational Qualification (OQ)
The key point is to establish a good dialogue with potential suppliers and make sure your needs are being met,
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Datum: 01.09.2020 - 06:01 Uhr
Sprache: Deutsch
News-ID 1560457
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