Adult Bovine Serum Defibrinated (ABSD) is obtained from blood taken from cattle deemed fit for human consumption following ante and post mortem veterinary inspection. The blood is collected in slaughter-houses supervised by government veterinarians.
The blood is collected into sanitary buckets and the fibrin is mechanically removed during the clotting process. The liquid component of the blood is pooled and separated using a continuous flow separator before being dispensed into either 5L Bottles or 25L Bladders and immediately frozen.
|SPECIFICATION - Adult Bovine Serum - Defribrinated Raw (ABSD)|
|Product||Adult Bovine Serum - Defibrinated Raw|
|Source||Bovine blood from healthy animals which have been inspected ante and post mortem by Australian or New Zealand Government veterinarians and passed as fit for human consumption.|
|Collection Method||Blood is collected into sanitary containers, defibrinated and centrifuged under temperature controlled conditions. It is then immediately frozen.|
|Description||Non sterile frozen orange liquid|
|Pack Size||5L bottles or 25L bladders or to Customer Specifications|
|Storage||- 20 degrees Centigrade|
|Haemoglobin||UV/VIS Spectrophotometer||As reported|
|Endotoxin||Kinetic Turbidimetric||As reported|
|Aerobic Microbial Count||CFU/ml||As reported|
|Total Protein||Beckman Coulter Synchron Clinical Systems||6.0 - 9.0 g/dl|
|pH||pH meter||6.5 - 8.0|
|Composition||CAE Agarose Gel Plate||Typical|
The European Pharmacopeia consists of a number of general and specific monographs covering various classes of products.
The monographs set out requirements to be met and followed for all products in the class.
Recently the EP has introduced a Monograph for Bovine Serum – Monograph No 04/2006:2262 to be found in E.P. 5.4
This monograph provides a definition of Bovine Serum and sets out details of production, and requirements for viral inactivation parameters, quality control testing, storage conditions and labelling.
Moregate Bovine Serum products meet these requirements and Certificates of Analysis are modeled on the QC test requirements.
The United States Pharmacopeia-National Formulary (USP-NF) contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.
Within the Pharmacopeia are Monographs and general chapters.
The monographs consist of information such as the ingredient name, definition, packaging and labelling requirements, storage and a specification.
The specifications list tests to be performed along with the procedure to be followed and the acceptable limit.
The European Directorate for the Quality of Medicines (EDQM) has originated from the European Pharmacopoeia Secretariat which, with the addition of new responsibilities changed its name to the European Department for the Quality of Medicines (EDQM). The EDQM sits alongside the European Medicines Agency (EMEA).
Amongst other activities, the EDQM is responsible for the European Pharmacopeia and the issuing of Certificates of Suitability (CEP).
Certificates of Suitability (CEP) are recognised by all signatory states of the European Pharmacopoeia Convention and by the European Union. Other countries have also chosen to recognise them. In the case of Fetal Bovine Serum and other Bovine Serum a CEP can be used by the manufacturers of Fetal Bovine Serum and other Bovine Serum which is intended for use in the manufacture of pharmaceutical products to demonstrate compliance with the Bovine Serum monographs of the European Pharmacopoeia and the EDQM requirements for substances concerned by TSE risk.
The discovery of Bovine Spongiform Encephalopathy (BSE), which is one of a group of similar infections now referred to as Transmissible Spongiform Encephalopathies (TSEs), and it’s spread over many countries of the European Union as well as its discovery in Canada, the USA and Japan is well known. The European events provided the impetus for the Council of Europe Public Health Committee (CEPHC) to pass Resolution AP-CSP (99) 5 addressing the TSE concerns and creating a Certificate of Suitability (COS) pursuant to Directive 75/318/EEC.
The granting of a CoS to a manufacturer, for a particular product, certifies that the product in question has been assessed for the level of risk of transmission of TSEs, and that the risk level is considered low enough that the product is certified as suitable for use in the manufacture of medicinal products in the European Union.
The process of approval requires the manufacturer to submit a dossier that covers all relevant aspects of the collection of raw material and further processing that is performed to reach the product that is offered to end users. This dossier is detailed and covers the specific material that is collected, the collection method, process validation, testing, traceability, quality systems and an expert review.
Only after this dossier has been examined and approved by two rapporteurs and, if necessary, by a panel of experts appointed by the European Directorate for the Quality of Medicines (EDQM) is the manufacturer granted a COS.
Moregate Biotech has been granted a COS for:
- Fetal Bovine Serum – Australian Origin – CEP2000-187
- Fetal Bovine Serum – New Zealand Origin – CEP2000-188
- Adult Bovine Serum - New Zealand Origin – CEP2001-093
- Adult Bovine Serum (Defibrinated) - New Zealand Origin – CEP2000-174
- Bovine Plasma – New Zealand Origin – CEP2003-199
- Bovine Serum Albumin – manufactured in Australia from New Zealand origin Bovine Plasma – CEP2003-205
- Bovine Plasma – Australian Origin - CEP 2005-192
- Bovine Serum Albumin – manufactured in Australia from Australian origin Bovine Plasma - CEP 2005-191
Copies of the Certificates of Suitability are available upon request
First Aid Measures
Get Medical attention immediately.
If swallowed, give several glasses of water to drink to dilute.
Wash skin with soap and copious amounts of water.
Flush with water for at least 15 minutes, lifting upper and lower eyelids occasionally.
Procedures for Personal Precaution
Exercise appropriate precautions to minimize direct contact with skin or eyes.
Methods for Cleaning Up
Ventilate area and wash spill site after material pickup is complete
Normal measures for preventive fire protection
Keep tightly closed under correct storage conditions
Contact a licensed professional waste disposal service to dispose of this material.
Note: The above information is believed to be correct, but shall be used as a guide only.
Disclaimer: For pharmaceutical use only.