Pharmaceutical Microbiology (eBook)

Best Practices, Validation, Quality Assurance

Michael Rieth (Autor)

eBook Download: EPUB

2025
743 Seiten
Wiley-VCH (Verlag)
978-3-527-84869-0 (ISBN)

Infos

All-in-one guide to monitoring and maintaining microbiological safety in the manufacturing of pharmaceuticals, diagnostics, and cosmetics

Addressing the full spectrum of microbiological quality control and quality assurance in pharmaceutical production, Pharmaceutical Microbiology covers methods and technologies required by regulatory authorities throughout the world, with all methods and protocols rated in terms of their compliance with current (2023) EU legislation.

Written by the former head of biological quality assurance for one of Europe's biggest pharmaceutical and diagnostics companies, Pharmaceutical Microbiology covers sample topics including:

• General conditions for the operation of microbiological laboratories, calibration and qualification of devices, and type culture maintenance
• Industrial hygiene, ambient monitoring, quality control, process validation, microbiological water examination, and rapid microbiological methods
• Automation in the microbiology laboratory, quality assurance, identification of microorganisms, cleaning, sterilization, decontamination, and disposal, and contract testing
• Pharmacopoeial and non-pharmacopoeial methods for the identification and quantification of microorganisms, including cell culture and selected animal tests

Pharmaceutical Microbiology is an essential practice-oriented all-in-one reference for engineers, researchers, and professionals involved in setting up and running a microbiological quality control unit in the pharmaceuticals, diagnostics, and cosmetics industries.

Michael Rieth received his biology doctorate from the Institute of Microbiology University of Gottingen. He entered into the pharmaceutical industry in 1988. From 1999 to 2014 he was Head of Biological Quality Assurance at Merck KGaA, Darmstadt. He then worked in the field of Global Regulatory Affairs until his retirement in 2020. He has written four books, including Pharmaceutical Microbiology in the German language, which was awarded the Wallhausser Prize in 2013.

Textauszug

List of Abbreviations

AL

Action limit or action level.

AMG

Arzneimittelgesetz.

AMWHV

Arzneimittel‐ und Wirkstoffherstellungsverordnung.

AP

Aqua purificata (purified water).

API

Analytical process index.

atm

Atmosphere.

ATCC

American Type Culture Collection.

ATP

Adenosine‐5′‐triphosphate.

aw

Water activity.

BfArM

Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Drugs and Medical Devices).

BG

Berufsgenossenschaft.

BG RCI

Berufsgenossenschaft Rohstoffe und Chemische Industrie (Employer's Liability Insurance Association for Raw Materials and the Chemical Industry).

BiostoffV

Biostoffverordnung.

BLV

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (Federal Office of Consumer Protection and Food Safety).

BMELV

Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz (Federal Ministry of Food, Agriculture and Consumer Protection).

BMwA

Bundesamt für wirtschaftliche Angelegenheiten (Austria).

BP

British Pharmacopeia or bubble point.

BPLS

Brilliant green Phenol red Lactose Sucrose Nutrient medium.

BRP

Biological reference preparation.

BSE

Bovine spongiform encephalopathy.

CCIT

Container closure integrity test.

CCOS

Culture Collection of Switzerland.

CDC

Centers for Disease Control and Protection.

CDCP

Centers for Disease Control and Prevention.

CFDA

5‐(6)‐carboxy‐fluorescein diacetate.

CHCA

α‐Cyano‐4‐hydroxycinnamic acid.

cft

Cubic feet.

CIP

Collection de l'Ínstitut Pasteur or cleaning in place.

CLED

Cysteine‐lactose‐electrolyte‐deficient culture medium.

cm

Centimeter.

CPM

Curriculum for Pharmaceutical Microbiology.

CSA

Casein Soymeal Peptone Agar (= TSA).

CSB

Casein Soymeal Peptone Broth (= TSB).

d

Day or diameter.

Da

Dalton, unit of relative molar mass, 1 Da = 1.66018 × 10 exp−24 g.

DAB

Deutsches Arzneibuch (German Pharmacopoeia).

DAkkS

Deutsche Akkreditierungsstelle.

DAPI

4′,6‐diamidine‐2‐phenylindole.

DEHS

Diethylhexylsebacic acid.

DEV

Deutsches Einheitsverfahren.

DGFM

Deutsche Gesellschaft für Mykologie e.V. (German Society for Mycology).

DGHM

Deutsche Gesellschaft für Hygiene und Mikrobiologie e.V. (German Society for Hygiene and Microbiology).

DIF

Direct immunofluorescence.

DIMDI

Deutsches Institut für Medizinische Dokumentation und Information (German Institute for Medical Documentation and Information).

DIN

Deutsche Industrienorm.

DKD

Deutscher Kalibrierdienst.

DMSO

Dimethyl sulfoxide.

DNA

Desoxyribonucleic acid.

DOP

Dioctyl phthalate.

DQS

Deutsche Gesellschaft zur Zertifizierung von Managementsystemen (German Association for the Certification of Management Systems).

DSM

Deutsche Sammlung von Mikroorganismen (German Collection of Microorganisms).

DSMZ

German Collection of Microorganisms and Cell Cultures.

EAME

Federal Office of Metrology (Switzerland).

ECCO

European Culture Collections Organization.

EDQM

European Directorate for the Quality of Medicines and Healthcare.

EDTA

Ethylenediaminetetraacetic acid.

EE

Endotoxin units.

EEU

Endotoxin equivalent unit.

EHEC

Enterohemorrhagic Escherichia coli.

ELC

Endotoxin limit concentration.

ELISA

Enzyme‐linked immuno sorbent assay.

EtOH

Ethanol.

EU

Endotoxin unit (1 EU = 1 IU = 1 IE).

FAME

Fatty acid methyl ester.

FDA

Food and Drug Administration.

FLI

Friedrich‐Löffler‐Institut.

GBF

Society for Biotechnological Research.

GenTG

Genetic Engineering Act.

GLP

Good laboratory practice.

GMP

Good manufacturing practice.

GSF

Society for Radiation and Environmental Research.

GVPC

Glycine, vancomycin, polymyxin, cycloheximide agar.

h

Hour.

HEPA

High efficiency particulate airfilter.

HRP

Horseraddish peroxidase.

HUS

Hemolytic uremic syndrome.

HZI

Helmholtz–Zentrum für Infektionskrankheiten GmbH.

IDA

International Depositary Authority.

IfSG

Infektionsschutzgesetz (Infection Protection Act).

IPA

Isopropyl alcohol (2‐propanol).

IPT

In vitro pyrogen test.

IQ

Installation qualification.

ISO

International Standardization Organization.

IU

International units.

ISSA

International Social Security Association.

JP

Japanese Pharmacopoeia.

CFU

Colony forming units.

λ

Lysate sensitivity Lambda.

l

Liter.

LAL

Limulus amoebocyte lysate.

LER

Low endotoxin recovery.

LF

Laminar flow.

LMX

Lauryl sulfate MUG X‐galactopyranoside.

LPS

Lipopolysaccharide.

LRW

LAL reagent water (Ph. Eur.: water for BEP) or limulus reagent water.

LTA

Lipoteichoic acid.

MALDI/TOF

Matrix‐assisted laser desorption/ionization – time of flight.

MAT

Monocyte activation test.

m‐CP

modified Cellobiosis Polymixin B Agar.

min

Minute.

MRI

Max‐Rubner Institute.

MRS

Lactobacillus agar according to de Man, Rogosa and Sharpe.

MVD

Maximum valid dilution.

NAT

Amplification of nucleic acids.

NCTC

National Collection of Type Cultures.

NCYC

National Collection of Yeast Cultures.

NP

Novopyrexal.

OB

Object carrier.

OOC

Out of calibration.

OD

Optical density.

ODC

Ornithine decarboxylase.

ÖKD

Österreichischer Kalibrierdienst.

OF

Oxidation/fermentation.

ONGP

o‐Nitrophenyl‐β‐D‐galactopyranoside.

OOE

Out of expectation.

OOL

Out of limit/out of level.

OOS

Out of specification.

OOT

Out of trend.

PAO

Polyalphaolefins.

PBS

Phosphate buffered saline.

PCR

Pseudoselagar or polymerase chain reaction.

PDA

Parenteral Drug Association.

PEI

Paul Ehrlich Institute.

Ph. Eur.

European Pharmacopoeia.

pNA

p‐Nitroaniline.

POD

Peroxidase.

PPC

Product Positive Control.

PPE

Personal protective equipment.

PVP

Polyvinylpyrrolidone (= Povidone).

PVDF

Polyvinylidene fluoride.

PTB

Federal Physical‐Technical Institute.

RCM

Reinforced clostridial medium.

SEM

Scanning Electron Microscopy.

RIA

Radioimmunoassay.

RKI

Robert–Koch–Institut.

RLU

Relative light unit or relative light units.

RNA

Ribonucleic acid.

rpm

Rotations per minute.

RRK

Clean room class (Reinraumklasse).

s

Second.

SAL

Sterility assurance level.

SARS

Severe acute respiratory syndrome.

SAS

Swiss Accreditation Service.

SDA

Sabouraud dextrose agar.

SIM

Sulfide and indole formation, motility.

SOP

Standard operation procedure.

TAMC

Total aerobic microbial count.

TEM

Transmission electron microscopy.

TierSeuchErV

Animal Disease Pathogen Ordinance.

TMB

Tetramethylbenzidine.

TRBA

Technical Rules Biological Agents.

TSA

Tryptic soybean agar.

TSB

Tryptic soybean bouillon.

TTC

Triphenyltetrazolium chloride.

TÜV

Technischer Überwachungsverein (Technical Inspection Agency, Germany).

TVO

(German) Drinking Water Ordinance.

TYMC

Total yeast and mold count.

U

Unit.

UF

Ultrafiltration.

UPU

World Postal Union.

USP

United States Pharmacopeia.

UVV

Accident prevention regulation.

VAAM

Vereinnigung für Allgemeine und Angewandte...

Produkt-Details

• Erscheint lt. Verlag: 25.2.2025
• Sprache: englisch
• Themenwelt: Naturwissenschaften ► Chemie
• ISBN-10: 3-527-84869-X / 352784869X
• ISBN-13: 978-3-527-84869-0 / 9783527848690