Validating cleaning procedures in biopharmaceutical manufacturing facilities

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The purpose of this informational chapter is to review the various issues that relate to aseptic processing of bulk drug substances, dosage forms, and in certain cases, medical devices; and to the establishment, maintenance, and control of the microbiological quality of controlled environments.This chapter includes discussions on (1) the classification of a clean room based on particulate count limits; (2) microbiological evaluation programs for controlled environments; (3) training of personnel; (4) critical factors in design and implementation of a microbiological evaluation program; (5) development of a sampling plan; (6) establishment of microbiological Alert and Action levels; (7) methodologies and instrumentation used for microbiological sampling; (8) media and diluents used; (9) identification of microbial isolates; (10) operational evaluation via media fills; and (11) a glossary of terms.4 (4.75-mm) Sieve and Finer for Metal-Bearing Ores and Related Materials E278-96e1 Standard Test Method for Phosphorus in Iron Ores (Titrimetric) E279-97 Standard Test Method for Determination of Abrasion Resistance of Iron Ore Pellets and Sinter by the Tumbler Test E280-98 Standard Reference Radiographs for Heavy-Walled (4 1/2 to 12-in.(114 to 305-mm)) Steel Castings E283-91 Standard Test Method for Determining the Rate of Air Leakage Through Exterior Windows, Curtain Walls, and Doors Under Specified Pressure Differences Across the Specimen E284-99a Standard Terminology of Appearance E285-80(1996)e1 Standard Test Method for Oxyacetylene Ablation Testing of Thermal Insulation Materials E287-94(1998) Standard Specification for Laboratory Glass Graduated Burets E288-94(1998) Standard Specification for Laboratory Glass Volumetric Flasks E289-99 Standard Test Method for Linear Thermal Expansion of Rigid Solids with Interferometry E290-97a Standard Test Method for Bend Testing of Material for Ductility E291-96 Standard Test Methods for Chemical Analysis of Caustic Soda and Caustic Potash (Sodium Hydroxide and Potassium Hydroxide) E292-83(1996)e1 Standard Test Methods for Conducting Time-for-Rupture Notch Tension Tests of Materials E294-72(1994) Standard Test Method for Effective Pumping Speed of Vacuum Chamber Systems E295-82(1992)e1 Standard Test Method for Measured Speed of Oil Diffusion Pumps E296-70(1994) Standard Practice for Ionization Gage Application to Space Simulators E298-98 Standard Test Methods for Assay of Organic Peroxides E299-97 Standard Test Method for Trace Amounts of Peroxides In Organic Solvents E300-92(1996) Standard Practice for Sampling Industrial Chemicals E301-94 Standard Test Method for Total Acidity of Organic Acids E302-95 Standard Test Methods for Monobasic Organic Acids E303-93(1998) Standard Test Method for Measuring Surface Frictional Properties Using the British Pendulum Tester E305-89(1994)e Standard Practice for Establishing and Controlling Spectrochemical Analytical Curves E307-72(1996)e1 Standard Test Method for Normal Spectral Emittance at Elevated Temperatures E308-99 Standard Practice for Computing the Colors of Objects by Using the CIE System E309-95 Standard Practice for Eddy-Current Examination of Steel Tubular Products Using Magnetic Saturation E310-99 Standard Reference Radiographs for Tin Bronze Castings E312-96 Standard Practice for Description and Selection of Conditions for Photographing Specimens E313-98 Standard Practice for Calculating Yellowness and Whiteness Indices from Instrumentally Measured Color Coordinates E314-95 Standard Test Methods for Manganese in Iron Ores E315-88(1999) Standard Test Methods for Chemical Analysis of Molybdenum E316-95a Standard Test Method for Determination of Iron in Manganese Ores by Hydrogen Sulfide Reduction-Dichromate Titration E317-94 Standard Practice for Evaluating Performance Characteristics of Ultrasonic Pulse- Echo Testing Systems Without the Use of Electronic Measurement Instruments E319-85(1997) Standard Practice for the Evaluation of Single-Pan Mechanical Balances E321-96 Standard Test Method for Atom Percent Fission in Uranium and Plutonium Fuel (Neodymium-148 Method) E322-96 Standard Test Method for X-Ray Emission Spectrometric Analysis of Low-Alloy Steels and Cast Irons E323-80(1996)e1 Standard Specification for Perforated-Plate Sieves for Testing Purposes E324-99 Standard Test Method for Relative Initial and Final Melting Points and the Melting Range of Organic Chemicals E326-96 Standard Test Method for Hydroxyl Groups by Phthalic Anhydride Esterification E328-86(1996)e1 Standard Test Methods for Stress Relaxation Tests for Materials and Structures E329-00 Standard Specification for Agencies Engaged in the Testing and/or Inspection of Materials Used in Construction E330-97e1 Standard Test Method for Structural Performance of Exterior Windows, Curtain Walls, and Doors by Uniform Static Air Pressure Difference E331-96 Standard Test Method for Water Penetration of Exterior Windows, Curtain Walls, and Doors by Uniform Static Air Pressure Difference E334-96 Standard Practice for General Techniques of Infrared Microanalysis E335-96 Standard Test Method for Hydroxyl Groups by Pyromellitic Dianhydride Esterification E336-97 Standard Test Method for Measurement of Airborne Sound Insulation in Buildings E337-84(1996)e1 Standard Test Method for Measuring Humidity with a Psychrometer (the Measurement of Wet- and Dry-Bulb Temperatures) E338-91(1997) Standard Test Method of Sharp-Notch Tension Testing of High-Strength Sheet Materials E340-95 Standard Test Method for Macroetching Metals and Alloys E341-96 Standard Practice for Measuring Plasma Arc Gas Enthalpy by Energy Balance E342-99 Standard Test Method for Chromium Oxide in Chrome Ores E343-96 Standard Test Method for Measuring Reaction Rates by Analysis of Molybdenum-99 Radioactivity From Fission Dosimeters E344-99 Terminology Relating to Thermometry and Hydrometry E345-93(1998) Standard Test Methods of Tension Testing of Metallic Foil E346-99 Standard Test Method for Analysis of Methanol E347-98 Standard Test Method for Ash in Polybasic Acids E348-69(1996)e1 Standard Practice for Man-Rated Space Facilities E349-72(1992) Standard Terminology Relating to Space Simulation E350-95(1997)e1 Standard Test Methods for Chemical Analysis of Carbon Steel, Low-Alloy Steel, Silicon Electrical Steel, Ingot Iron, and Wrought Iron E351-93(1997)e1 Standard Test Methods for Chemical Analysis of Cast Iron-All Types E352-93(1997)e1 Standard Test Methods for Chemical Analysis of Tool Steels and Other Similar Medium- and High-Alloy Steels E353-93(1997)e1 Standard Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys E354-93(1997)e1 Standard Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and Cobalt Alloys E355-96 Standard Practice for Gas Chromatography Terms and Relationships E356-78(1996) Standard Practices for Describing and Specifying the Spectrograph E357-98 Standard Test Method for Phosphorus in Organic Compounds by Sodium Peroxide Bomb Ignition E358-95 Standard Test Methods for Analysis of Phosphoric Acid E359-95 Standard Test Methods for Analysis of Soda Ash (Sodium Carbonate) E360-96 Standard Test Methods for Chemical Analysis of Silicon and Ferrosilicon E361-99 Standard Test Methods for the Determination of Arsenic and Lead in Ferromanganese E362-99 Standard Test Methods for the Determination of Arsenic and Lead in Silicomanganese and Ferrosilicon Manganese E363-83(1997)e1 Standard Methods for Chemical Analysis of Chromium and Ferrochromium E364-94 Standard Test Methods for Chemical Analysis of Ferrochrome-Silicon E365-99 Standard Test Methods for the Determination of Vanadium in Ferrovanadium and Vanadium Alloying Additives E367-83(1997)e1 Standard Methods for Chemical Analysis of Ferrocolumbium E371-89(1995)e1 Standard Test Methods for Chemical Analysis of Ferroboron E372-84(1996) Standard Test Method for Chemical Analysis of Magnesium Ferrosilicon E376-96 Standard Practice for Measuring Coating Thickness by Magnetic-Field or Eddy-Current (Electromagnetic) Test Methods E377-96 Standard Practice for Internal Temperature Measurements in Low-Conductivity Materials E378-97 Standard Test Method for Spectrographic Analysis of Silver by the Powder Technique E381-98 Standard Method of Macroetch Testing Steel Bars, Billets, Blooms, and Forgings E382-97 Standard Test Method for Determination of Crushing Strength of Iron Ore Pellets E384-99 Standard Test Method for Microindentation Hardness of Materials E385-90 Standard Test Method for Oxygen Content Using a 14-Me V Neutron Activation and Direct-Counting Technique E386-90(1995)e1 Standard Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy E387-84(1995)e1 Standard Test Method for Estimating Stray Radiant Power Ratio of Spectrophotometers by the Opaque Filter Method E388-72(1998) Standard Test Method for Spectral Bandwidth and Wavelength Accuracy of Fluorescence Spectrometers E389-93(1998) Standard Test Method for Particle Size or Screen Analysis at No.By observing car traffic and stopping until the car has passed or looking for a pedestrian crossing or traffic lights we can eliminate the risk that the car will hit us.

Numerical values included in this chapter are not intended to represent absolute values or specifications, but are informational.We experience this every day long before we start our daily work.Before we cross a busy road on the way to our workplace, we look left and right because there is a risk that a car may appear and run us over.Experiences from speaking at the DIA USA in June 2017; read about the challenges of a global pharmacovigilance system and strategies to manage it.During the DIA USA in June 2017, I was one of the three speakers in the session: The Brave New World; The Ongoing globalisation of Pharmacovigilance (#320).The main topic of this session was how to manage a global Pharmacovigilance system.

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