|Contract Manufacture of Biological Substances|
Sterile, ultra- and prefiltrations, extractions and separations of biological substances according to GMP conditions.
To utilize free capacities we do contract manufacture on a regular basis.
At Kraeber, we work and supply full documentation according to cGMP standards.
We have been certified by DNV Zertifizierung- und Umweltgutachter GmbH (Det Norske Veritas Germany) with EN ISO 9001:2000.
Registered according to EC Nr. 1069/2009
Kraeber has been registered according to article 24 of the European regulation for animal by-products under number: DE01056000403.
We have been registered according to § 17 FMG (German Feed Law) as a supplier for sole and premixed feed.
|We have:||We carry out:||Our Equipment:|
- Clean room: class B/US 100 with a class A/US 10 area
- Clean rooms : class B, class C, class D, air-conditioned
- Laboratory for analytical tests
- Storage room for deep-freezing -20 to -28 °C
- Rooms for controlled thawing
- Working room +2/+5 °C
- Fractionation of animal blood
- Extraction from animal tissue
- Sterile filtration
- Heat inactivation in large batches
- Several filtration units for:
- Sterile filtration
- Suction filter
- Heat tank with stirrer
- Beaker centrifuges, cooled
- Flow centrifuges (Cepa + Carr)
- Disc bowl centrifuges
- Vacuum dryer
- Clean water system
- Steam processor
- Various dosing pumps
Contract Filtration Services
We offer a comprehensive contract service for the filtration of serum and other liquids, such as Fetal Calf Serum, under the following conditions:
- Strict control of incoming materials.
- Storage of frozen materials at -20 °C. Controlled thawing according to your instructions.
- Pooling of your material and preparation of samples to your requirements, Ph.EUR, or USP. Safe disposal of packing materials by us.
- Sterile filtration takes place to your requirements using single, double or triple filter sets.
- Pooling of sterile liquids upon request.
- Preparation of your bottles and bottling of the product in a Class B clean room with a Class A area. Separation of samples. Bottles used for packaging can be provided upon request and at cost.
- Labelling and sealing of your bottles.
- Freezing and storage at -20 °C until charge is released.
- Packing of bottles into cartons labeled according to your instructions.
- Dispatch of samples to an independent laboratory for testing the sterility according to USP or Ph.EUR.
Additional tests can be organised upon request. A sterilisation certificate is provided with each charge. Should any testing show non-sterility of production, then the re-working and testing will be done at our cost.
We recommend to take into consideration the loss of material during a filtration process; when calculating the quantitiy of the incoming material.
Our liability is restricted to sterility as per USP 29 or Ph.EUR.
- Delivery as agreed with customers.
Heat Inactivation · pH-Reduction · Gamma-radiation
Heat inactivation is the method of choice for many investigators to ensure that cells will not be lysed by antibody binding. It is most commonly used to destroy the complement binding capacity.
Heat inactivation of small serum quantities is normally performed in a water bath. This serum often contains flocculent materials, primarily lipoproteins, which have to be removed for some purposes.
It is more efficient to inactivate sera after sterile filtration.
Due to the high sensitivity of serum components the procedure is difficult to perform. A minimum temperature of 56 °C +-1 °C should be attained for 30 minutes.
We have installed a facility which allows us to inactivate sera in batches up to 2.000 l under controlled and reproducible conditions. The process needs max. 60 minutes for heating up to 56 °C and max. 90 minutes for cooling down to 7 °C.
We are also offering to our customers the heat inactivation service according to EU-regulations.
Inactivation of viruses by pH-reduction is possible in batch sizes up to 1.000 l.
We have established logistics for the gamma-radiation of our products. Please ask for special information.