Multilab-Logo, India
 New No.3, Appaiar Lane, Second Floor, Royapuram, Chennai - 600 013, Tamilnadu, India
 Email - enquiry@multilab.biz, Tele Fax - +9144 52173177,  Mobile - +91 94441 62346    
FAQ
Language    Search
  Cleanrooms Laboratory
  Pharmaceutical Testing



FAQ > Glossary of Terms > B Series > Baseline Pharmaceutical Engineering Guides
 

Cleanrooms Information

Pharmaceutical & Cleanroom Glossary of Terms

BAC(Bacterial Artificial Chromosome), Background Contamination, Background Environment, Back-up Copy, Backward Compatibility, Backwash, Bacteria, Bactericide, Bacteriophage, Bacteriostatic, Bacteriostatic Water, Bacterium, Barrier Isolator, Barrier Technology, Base, Base Pair(bp), Base Sequence, Baseline Pharmaceutical Engineering Guides, Basidiomycetes, Basis of Design, Batch, Batch Number, Batch Fermentation, Bed, Bed Depth, Bed Expansion, Binary Explosive, Bioactivity, Bioassay, Bioaugmentation, Biochemical Oxygen Demand(BOD), Biocide, Biodegradable, Bioequivalency, Biogenerator, Biohazard, Bioinformatics, Biologic, Biological Barrier, Biological Impurities, Biological Indicators, Biological Oxygen Demand(BOD), Biological Reactivity Tests - In Vivo, Biological Safety Cabinets(BSCs), Biologics, Biomass, Biometabolism, Biometrics, Bionics, Biopharmaceuticals, Bio Processing, Bioprocessing Engineering, Biopsy, Bio Pure Water, Biosphere, Bioreactor, Biosafety Level, Biosynthesis, Biotechnology, Biowaste Inactivation, BLA(Biologics License Application), Blank, Blind Weld, Blood Borne Pathogens, Blood Carpuscle, Blood Plasma, Blood Platelets, Blood Serum, Blow Down, Blow(Form) Fill - Seal, BME(Basic Medium Eagles), BPC(Bulk Pharmaceutical Chemical), BSA(Bovine Serum Albumin), BSE(Bovine Spongiform Encephalopathy), BSD(Bovine Viral Diarrhea), Braze Welding, Brazing, Brakethrough, Breath Control Shields, Broad Spectrum, Broth, Btu(British Test Unit), Bubble Point Test, Buffer, Buffer Prep, Building Occupancy Classification(California Building Code), Bulk Handling, Bulk Oxygen System, Byte, Bioburden, Biochemistry, Blinding


Learn About Deadly Cancer Mesothelioma due to Asbestos Exposure, it can affect any one in the world

Baseline® Pharmaceutical Engineering Guides (ISPE)
A series of industry publications developed in partnership with the US Food and Drug Administration (FDA). Each volume in the series is a collaborative effort of industry leaders representing a broad cross-section of manufacturers and other industry experts. The Guides document current industry practice for facilities and systems used for production of pharmaceutical products and medical devices. They are intended to:
  • Establish a baseline approach to new and renovated facility design, construction, commissioning, and qualification that is based upon clear understanding of the type of product and its manufacturing process.
  • Prioritize facility design features based upon the impact on product and process.
  • Avoid unnecessary spending on facility features that do not contribute to consistent production of quality products.
The Guides include five product manufacturing operation based guides (vertical guides), and three support system/function based guides (horizontal guides):
1. Volume I - Bulk Pharmaceutical Chemicals (1996)
2. Volume II - Oral Solid Dosage Forms (1998)
3. Volume III - Sterile Manufacturing Facilities (1999)
4. Volume VI - Biotech (in progress)
5. Volume -Oral Liquids and Aerosols
6. Volume IV - Water and Steam Systems (in progress)
7. Volume V - Commissioning and Qualification Guide (in progress)
8. Volume VII - Packaging and Warehousing