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当前位置: 首页 > 产品中心 > serum > Moregate/Bovine Calf Serum - Sterile Filtered (BCSF)/null/BCSF
商品详细Moregate/Bovine Calf Serum - Sterile Filtered (BCSF)/null/BCSF
Moregate/Bovine Calf Serum - Sterile Filtered (BCSF)/null/BCSF
Moregate/Bovine Calf Serum - Sterile Filtered (BCSF)/null/BCSF
商品编号: BCSF
品牌: moregatebiotech
市场价: ¥20.00
美元价: 10.00
产地: 美国(厂家直采)
公司:
产品分类: 血清
公司分类: serum
联系Q Q: 3392242852
电话号码: 4000-520-616
电子邮箱: info@ebiomall.com
商品介绍

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.

SPECIFICATION - Bovine Calf Serum - Sterile Filtered (BCS)
ProductBovine Calf Serum - Sterile Filtered
Catalogue No.BCSF
SourceBovine 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 MethodBlood 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.
DescriptionA clear orange viscous liquid with a characteristic odour.
Pack Size500ml sterile PET & PETG "Nalgene" bottles
Storage- 20 degrees Centigrade
Expiry DateSix years from the date of manufacture
TestMethodSpecification
Visual ExaminationVisualSatisfactory
SpecificitySpecies I.D.Bovine
SterilityMillipore Steritest Broth Culture 14 Day IncubationSterile
MycoplasmaBroth Culture 35 Day IncubationNot detected
VirusesModified 9CFR
Bovine Viral Diarrhea Virus (BVDV)Fluorescent AntibodyNot Detected
Infectious Bovine RhinotracheitisCytopathic agentsNot Detected
Para Influenza 3 (PI3)Haemadsorbing AgentsNot Detected
Antibodies
BVDVVNTAs reported
IBRVNTAs reported
PI3ElisaAs reported
pHpH Meter6.9 - 7.9
OsmolalityOsmometer240 - 340 mOsmol/kg
Total ProteinBeckman Coulter Synchron ClinicalSystems≥35 mg/ml
AlbuminElectrophoresisAs Reported g/l
Gamma GlobulinsElectrophoresisAs Reported mg/ml
HaemoglobinUV/VIS Spectrophotometer≤ 0.35 mg/ml
EndotoxinKinetic - Turbidimetric≤ 30 IU/ml
BIOCHEMICAL PROFILE - Beckman DXC 800 Analyser
SodiumAs Reported mmol/l
PotassiumAs Reported mmol/l
ChlorideAs Reported mmol/l
BicarbonateAs Reported mmol/l
Anion GapAs Reported mmol/l
GlucoseAs Reported mmol/l
UreaAs Reported mmol/l
CreatinineAs Reported µmol/l
Urea/CreatinineAs Reported (ratio)
UrateAs Reported mmol/l
Bilirubin totalAs Reported µmol/l
CalciumAs Reported mmol/l
Calcium (Alb Corr.)As Reported mmol/l
PhosphateAs Reported mmol/l
Alkaline PhosphataseAs reported U/l
Gamma Glutamyl TransferaseAs reported U/l
Alanine Transaminase (Glutamic Pyruvic Transaminase)As reported U/l
Aspartate Transaminase (Glutamic Oxaloacetic Transaminase)As reported U/l
Lactate DehydrogenaseAs reported U/l
CholesterolAs Reported mmol/l
TriglycerideAs Reported mmol/l

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.

EMEA/CPMP/CVMP

The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. It sits alongside the European Directorate for the Quality of Medicines (EDQM).

The main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

The EMEA publishes guidelines on quality, safety and efficacy testing requirements.

These guidelines are prepared by committees, and those guidelines which relate to the use of Bovine Serum, including Fetal Bovine Serum, in the manufacture of medicines include:

CPMP: Committee for Proprietary Medicinal Products

Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products

Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. (Also adopted by the CVMP)

CVMP: Committee for Veterinary Medicinal Products

Requirements and Controls applied to Bovine Serum used in the production of Immunological Veterinary Medicinal products.

These Guidelines include requirements for Virus Testing of Fetal Bovine Serum and other Bovine Serum. Further reference to these requirements can be found in “Virus Testing”. 

All Moregate Biotech Fetal Bovine Serum and other Bovine Serum meet the requirements of the Guidelines in relation to Fetal Bovine Serum and Bovine Serum.

USDA 9CFR Part 113.53c

Ingredients of animal origin used in the United States of America, in the manufacture of veterinary and human biologics are required to be in compliance with the Code of Federal Regulations, Title 9 – Animals and Animal Products, Chapter 1 - Animal and Plant Health Inspection Service, Department of Agriculture Part 113-53c, commonly referred to as 9CFR Part 113-53c.

This legislation sets out the requirements for detection of extraneous viruses, detailing the methods to be used and the list of viruses that shall be tested for.  

Over time 9CFR Part 113-53c became the accepted standard for the testing of animal sera, particularly Fetal Bovine Serum for adventitious viral agents.

Bovine Respiratory Syncytical Virus, Bovine Viral Diarrhea Virus, Bovine Parvovirus, Bluetongue Virus, Bovine Adenovirus, Rabies Virus and Reovirus are tested for by fluorescent antibody

Infections Bovine Rhinotracheitis tested for by Cytopathic Agents.

Infectious Influenza 3 tested for by Haemadsorbing Agents

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.

品牌介绍
Moregate Biotech 公司在澳大利亚的布里斯班和新西兰的汉密尔顿都建有符合GMP条件的生产设施,产品的原材料分别取自澳大利亚和新西兰。自公司成立以来,已经为各大国际制药企业和众多研究机构提供产品、原料和服务,在世界各地范围内,Moregate都赢得了良好产品声誉和客户满意度。