Bovine Calf Serum - Sterile Filtered (BCSF)
Bovine Calf Serum (BCS) is obtained from blood taken from Bovines aged average of 18 months, 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 allowed to clot naturally and is then centrifuged to obtain the liquid fraction of the blood which is now regarded as semi-processed serum. No other additions or deletions of material are permitted.
STERILE FILTERED: Semi-processed Raw Bovine Calf Serum, is thawed, pooled and filtered through a series of sterile membranes down to 0.2 microns before being finally packaged, usually in 500ml or 1L bottles. No further processing, additions or deletions are performed.
| Available Treatments - Bovine Calf Serum - Sterile Filtered (BCSF) | |
| IRRADIATED | Gamma Irradiation of Sterile Filtered BCSF takes place in Brisbane at an Australian Government licensed gamma irradiation facility. Frozen serum is irradiated following Moregate Biotech's validated procedure to a customer specified dose range. A gamma irradiation indicator (colour change) is applied to every container before irradiation. A Certificate of Irradiation is issued for every lot of irradiated serum. |
| SPECIFICATION - Bovine Calf Serum - Sterile Filtered (BCS) | |
| Product | Bovine Calf Serum - Sterile Filtered |
| Catalogue No. | BCSF |
| Source | Bovine blood from healthy Bovines aged average of 18 months which have been inspected ante and post mortem by Australian Government veterinarians and passed as fit for human consumption. |
| Collection/Processing Method | Blood is collected into aseptic containers, defibrinated and centrifuged under temperature controlled conditions. Serum is subsequently passed through a series of filters terminating with 0.2 micron pore size sterilising grade filters. Product is dispensed in Class 100 Laminar Flow Workstation via a closed system. It is then immediately frozen. |
| Description | A clear orange viscous liquid with a characteristic odour. |
| Pack Size | 500ml sterile PET & PETG "Nalgene" bottles |
| Storage | - 20 degrees Centigrade |
| Expiry Date | Six years from the date of manufacture |
| Test | Method | Specification | |||||||||
| Visual Examination | Visual | Satisfactory | |||||||||
| Specificity | Species I.D. | Bovine | |||||||||
| Sterility | Millipore Steritest Broth Culture 14 Day Incubation | Sterile | |||||||||
| Mycoplasma | Broth Culture 35 Day Incubation | Not detected | |||||||||
| Viruses | Modified 9CFR | ||||||||||
|
|||||||||||
| Antibodies | |||||||||||
|
|||||||||||
| pH | pH Meter | 6.9 - 7.9 | |||||||||
| Osmolality | Osmometer | 240 - 340 mOsmol/kg | |||||||||
| Total Protein | Beckman Coulter Synchron Clinical Systems | ≥ 35 mg/ml | |||||||||
| Albumin | Electrophoresis | As Reported g/l | |||||||||
| Gamma Globulins | Electrophoresis | As Reported mg/ml | |||||||||
| Haemoglobin | UV/VIS Spectrophotometer | ≤ 0.35 mg/ml | |||||||||
| Endotoxin | Kinetic - Turbidimetric | ≤ 30 IU/ml | |||||||||
| BIOCHEMICAL PROFILE - Beckman DXC 800 Analyser | ||
| Sodium | As Reported mmol/l | |
| Potassium | As Reported mmol/l | |
| Chloride | As Reported mmol/l | |
| Bicarbonate | As Reported mmol/l | |
| Anion Gap | As Reported mmol/l | |
| Glucose | As Reported mmol/l | |
| Urea | As Reported mmol/l | |
| Creatinine | As Reported µmol/l | |
| Urea/Creatinine | As Reported (ratio) | |
| Urate | As Reported mmol/l | |
| Bilirubin total | As Reported µmol/l | |
| Calcium | As Reported mmol/l | |
| Calcium (Alb Corr.) | As Reported mmol/l | |
| Phosphate | As Reported mmol/l | |
| Alkaline Phosphatase | As reported U/l | |
| Gamma Glutamyl Transferase | As reported U/l | |
| Alanine Transaminase (Glutamic Pyruvic Transaminase) | As reported U/l | |
| Aspartate Transaminase (Glutamic Oxaloacetic Transaminase) | As reported U/l | |
| Lactate Dehydrogenase | As reported U/l | |
| Cholesterol | As Reported mmol/l | |
| Triglyceride | As Reported mmol/l | |
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.
PO Box 654
Bulimba QLD 4171, Australia info@moregatebiotech.com Tel: +61 (7) 6473 3997 Fax: +61 (7) 6173 3995