BOOKS & STANDARDS FOR PHARMACEUTICAL INDUSTRY

HVAC DESIGN
ASHRAE 62.1 Ventilation for ACC – Acceptable Indoor Air Quality
ASHRAE 189 Standard for the Design of High-Performance Green Buildings
ASHRAE 90.1 Energy Standard for Buildings Except Low-Rise Residential Buildings
ASHRAE RP – 1673 ASHRAE Supertall & Mega-tall Building Systems
ASHRAE RP Load Calculation Application Manual by – Jeffrey D Spilter
ASHRAE RP Understanding Psychrometrics by – Donald P. Gatley
CARRIER
 		 Carrier Hand Books 1 – 12
ASHRAE HAND BOOKS (4 Volumes)
CLEANROOM DESIGN
VOLUME 1 Clean-Room Designing – By Wiley
VOLUME 2 Cleanroom-Technology-Fundamentals-of-Design-Testing-And-Operation – By Wiley
CLEANROOM STANDARDS
ISO 14644-1 Classification of air cleanliness by particle concentration. Covers the classification of air cleanliness in cleanrooms and associated controlled environments.
ISO 14644-2
 		 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration. Specifies requirements for monitoring and periodic testing of a cleanroom or clean zone to prove its continued compliance with ISO 14644-1.
ISO 14644-3 Test methods, specifies test methods for designated classification of airborne particulate cleanliness for characterizing the performance of cleanrooms and clean zones.
ISO 14644-4 Design, construction, and start-up. Specifies requirements for the design and construction of cleanroom installations. ISO 14644-5 Operations. Specifies basic requirements for cleanroom operations.
ISO 14644-5 Operations. Specifies basic requirements for cleanroom operations
ISO 14644-7
 		 Separative devices (clean air hoods, gloveboxes, isolators, mini environments). Specifies the minimum requirements for the design, construction, installation, testing and approval of separative devices.
ISO 14644-8 Classification of air cleanliness by chemical concentration. Covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments.
ISO 14644-9 Classification of surface particle cleanliness. Establishes the classification of cleanliness levels on solid surfaces by particle concentration in cleanrooms and associated controlled environments.
ISO14644-10
 		 Classification of surface cleanliness by chemical concentrations. Defines the classification system for cleanliness of surfaces in cleanrooms with regard to the presence of chemical compounds or elements.
ISO/DIS 14644 -12
 		 Specifications for monitoring air cleanliness by nanoscale particle concentration. Covers the monitoring of air cleanliness by particles in terms of concentration of airborne nanoscale particles.
ISO/DIS 14644 -13
 		 Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications. Addresses the cleaning to a specified degree on cleanroom surfaces, surfaces of equipment in a cleanroom and surfaces of materials in a cleanroom.
ISO14644-14
 		 Assessment of suitability for use of equipment by airborne particle concentration. Specifies a methodology to assess the suitability of equipment for use in cleanrooms and associated controlled environments.
ISO/DIS 14644 – 15
 		 Assessment of suitability for use of equipment and materials by airborne chemical concentration.
Provides requirements and guidance for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments.
ISPE: GOOD PRACTICE GUIDE
VOLUME 1 Bulk Pharmaceutical Chemicals
VOLUME 2 Oral Solid Dosage Forms
VOLUME 3 Sterile Manufacturing Facilities
VOLUME 4 Water & Steam Systems
VOLUME 5 Pharmaceutical Engineering Guides
HVAC Heating, Ventilation & Air-Conditioning
IEST: CONTAMINATION CONTROL RECOMMENDED PRACTICES
CC – 001 HEPA and ULPA Filters
CC – 002 Unidirectional-Flow, Clean-Air Devices
CC – 003 Garment System Considerations for Cleanrooms and Other Controlled Environments
CC – 004 Evaluating Wiping Materials Used in Cleanrooms and Other Controlled Environments
CC – 005 Gloves and Finger Cots Used in Cleanrooms and Other Controlled Environments
CC – 006 Testing Cleanrooms
CC – 007 Testing ULPA Filters
CC – 008 High-Efficiency Gas-Phase Adsorber Cells
CC – 009 Compendium of Standards, Practices, Methods, and Similar Documents Relating to Contamination Control
CC – 011 A Glossary of Terms and Definitions Relating to Contamination Control
CC – 012 Considerations in Cleanroom Design
CC – 013 Calibration Procedures and Guidelines for Select Equipment Used in Testing Cleanrooms and Other Controlled Environments
CC – 014 Calibration and Characterization of Optical Airborne Particle Counters
CC – 016 The Rate of Deposition of Non-volatile Residue in Cleanrooms
CC – 018 Cleanroom Housekeeping: Operating and Monitoring Procedures
CC – 019 Qualifications for Organizations Engaged in the Testing and Certification of Cleanrooms and Clean-Air Devices
CC – 020 Substrates and Forms for Documentation in Cleanrooms
CC – 021 Testing HEPA and ULPA Filter Media
CC – 022 Electrostatic Charge in Cleanrooms and Other Controlled Environments
CC – 023 Microorganisms in Cleanrooms
CC – 024 Measuring and Reporting Vibration in Microelectronics Facilities
CC – 025 Evaluation of Swabs Used in Cleanrooms
CC – 026 Cleanroom Operations
CC – 027 Personnel Practices and Procedures in Cleanrooms and Controlled Environments
CC – 028 Minienvironments
CC – 029 Contamination Control Considerations for Paint-Spray Applications
CC – 031 Method for Characterizing Outgassed Organic Compounds from Cleanroom Materials and Components
CC – 032 Flexible Packaging Materials for Use in Cleanrooms and Other Controlled Environments
CC – 034 HEPA and ULPA Filter Leak Tests
CC – 035 Design Considerations for Airborne Molecular Contamination Filtration Systems in Cleanrooms
CC – 036 Testing Fan Filter Units
CC – 040 Cleaning of Equipment Surfaces in the Cleanroom and Controlled Environments
CC – 041 Recovery from Disruption to Cleanrooms and Other Controlled Environments
CC – 042 Sizing and Counting of Sub-Micrometer Liquid-Borne Particles Using Optical Discrete-Particle Counters
CC – 043 Surface Molecular Contamination
CC – 044 Vacuum Cleaners and Systems for Cleanrooms and Other Controlled Environments
CC – 045 Design Considerations for Critical Exhaust Systems
CC – 046 Contamination Control in Controlled Environments
CC – 047 Cleanroom Lighting
CC – 048 Guidance for Design, Performance, and Operations of Controlled Environments per USP 797
CC – 101 Forum on Air Cleanliness Technology (Technical Guides IEST-G-CC – 1001, IEST-G-CC – 1002, IEST-G-CC – 1003, IEST-G-CC – 1004)
CC – 901 Product Cleanliness Levels and Contamination Control Program (IEST-STD-1246)
CC – 902 MIL-HDBK-406: Contamination Control Technology: Cleaning Materials for Precision Pre- Cleaning and Use in Cleanrooms and Clean Work Stations; MIL-HDBK-407: Contamination Control Technology: Precision Cleaning Methods and Procedures.
BIOCONTAMINATION STANDARDS
ISO 14698-1 Bio contamination Control General Principles describes the principles and basic methodology for a formal system to assess and control biocontamination, where cleanroom technology is applied, in order that biocontamination in zones at risk can be monitored in a reproducible way and appropriate control measures can be selected. In zones of low or negligible risk this standard may be used as a source of information.
ISO 14698-2 Bio contamination Evaluation & Interpretation Data of biocontamination data, gives guidance on basic principles and methodological requirements for all microbiological data evaluation, and the estimation of biocontamination data obtained from sampling for viable particles in zones at risk, as specified by the system selected. This is not intended for testing the performance of microbiological counting techniques of determining viable units.
RECOMMENDED STANDARD
AHRI 550-590 Performance Rating of Water-Chilling and Heat Pump Water-Heating Packages Using the Vapor Compression Cycle
AHRI 410 Forced-Circulation Air-Cooling and Air-Heating Coils
AHRI 430 Performance Rating of Central Station Air-Handling Units (Fan Rating)
EN – 1886 Air Handling Units Mechanical performance
EN – 13053 Air Handling Units Ratings and performance
EN – 779 Filter Efficiency
EN – 1822 Test methods for EPA, HEPA and ULPA filters
AMCA – 210 Testing Fans
AMCA – 211 Fan Air Performance
NAFA Guide to Air Filtration
NEBB HVAC Testing, Adjusting & Balancing

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