Adult Bovine Serum Clarified (ABSC) 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.
ABSC is prepared from Adult Bovine Serum - Raw (ABSR). This serum is thawed in a temperature controlled environment, and passed through a series of clarifying filters terminating with either a 0.45µm or 0.2 µm pore sized filter. It is then then dispensed into 5L containers and immediately frozen
| SPECIFICATION | |
| Product | Adult Bovine Serum - Clarified |
| Catalogue No. | ABSC |
| 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 collected and processed using the ABSR method is thawed in a temperature controlled environment, and passed through a series of clarifying filters terminating with either a 0.45µm or 0.2 µm pore sized filter. It is then dispensed into 5L containers and immediately frozen. No further processing additions or deletions are performed. |
| Description | Non sterile frozen orange liquid |
| Pack Size | 5 Litre HDPE container or to Customer Specifications |
| Storage | - 20 degrees Centigrade |
| Test | Method | Specification | |||||||||
| Visual Examination | Visual | Satisfactory | |||||||||
| Viruses | Modified 9CFR (113 - 53c) | ||||||||||
| |||||||||||
| pH | As reported | ||||||||||
| Osmolality | Osmometer | 240-320 mOsmol/kg | |||||||||
| Total Protein | Beckman Coukter Synchron Clinical Systems | 45 - 85 mg/ml | |||||||||
| Albumin | Electrophoresis | As reported | |||||||||
| Haemoglobin | UV/VIS Spectrophotometer | < 4 mg/ml | |||||||||
EP/USP
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.
Hazards Identification
- Not hazardous
- Get Medical attention immediately
First Aid Measures
Get Medical attention immediately.
Ingestion
If swallowed, give several glasses of water to drink to dilute.
Skin Contact
Wash skin with soap and copious amounts of water.
Eye Contact
Flush with water for at least 15 minutes, lifting upper and lower eyelids occasionally.
Accidental Release
Procedures for Personal Precaution
Exercise appropriate precautions to minimize direct contact with skin or eyes.
Methods for Cleaning Up
Mop up
Ventilate area and wash spill site after material pickup is complete
Handling and Storage
Handling
Normal measures for preventive fire protection
Storage
Keep tightly closed under correct storage conditions
Exposure Controls / Personal Protection
- Wash thoroughly after handling.
- Protective gloves
Disposal Considerations
Contact a licensed professional waste disposal service to dispose of this material.
Transport Information
- Non-hazardous for road transport
- Non-hazardous for sea transport
- Non-hazardous for air transport
Note: The above information is believed to be correct, but shall be used as a guide only.
Disclaimer: For pharmaceutical use only.
Moregate一直视产品的品质为公司生存的根本。 ü 对生产过程中的每一个环节都严格控制 Ø 采用欧盟和美国无菌采集标准， Ø Moregate的质量体系严格执行ISO9001:2008 和 cGMP标准 ü 严格的检测与质控体系 Ø 产品经EDQM（欧洲药品质量管理局）验证符合欧洲药典标准 Ø 质控体系包括自检与第三方检测 Ø 在需要的时候，产品经专门检测符合以下机构的要求 - European Pharmacopeia欧洲药典 - USP美国药典 - EMEA/CPMP/CVMP欧洲药品评估局/药品委员会 - USDA 9CFR Part 113 - 53c美国农业部 Ø Moregate胎牛血清质控项目
