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FAQ
> Glossary of Terms > B Series > Baseline
Pharmaceutical Engineering Guides
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Pharmaceutical & Cleanroom Glossary of Terms
A Series , B Series ,
C Series , D
Series , E Series , F
Series , G Series , H
Series , I Series , K
Series , L Series , M
Series , N Series , O
Series , P Series , Q
Series , R Series , S
Series , T Series , U
Series , V Series , W
Series , X
Series , Y Series , Z
Series
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
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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
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