• IEST USP 797 Handbook

IEST USP 797 Handbook

  • USP 797 Handbook
  • Handbook / Manual / Guide by Institute of Environmental Sciences
  • Category: IEST

$3,660.00 $1,830.00

USP 797 requires compounding pharmacies to determine the risk level of the compounding done in their facilities and to perform the compounding in cleanrooms or other controlled environments as specified for the risk level. The documents in this Handbook will help users:
  • Determine, design, and maintain the proper controlled environment for your application.
  • Develop standard procedures for cleaning the controlled environment.
  • Implement environmental sampling to monitor air quality regularly for viable and nonviable particles.
  • Develop standard procedures for personnel gowning and gloving.

CONTENTS
  • ISO 14644-1 Classification of air cleanliness
  • ISO 14644-2 Specifications for testing and monitoring to prove continued compliance with 14644-1
  • ISO 14644-4 Design, construction and start-up
  • ISO 14644-5 Operations
  • ISO 14644-7 Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)
  • IEST-RP-CC001HEPA and ULPA Filters
  • IEST-RP-CC002Unidirectional Flow Clean-Air Devices
  • IEST-RP-CC003Garment System Considerations for Cleanrooms and Other Controlled Environments
  • IEST-RP-CC006Testing Cleanrooms
  • IEST-RP-CC007Testing ULPA Filters
  • IEST-RP-CC012Considerations in Cleanroom Design
  • IEST-RP-CC018Cleanroom Housekeeping - Operating and Monitoring Procedures
  • IEST-RP-CC020Substrates and Forms for Documentation in Cleanrooms
  • IEST-RP-CC023Microorganisms in Cleanrooms
  • IEST-RP-CC026Cleanroom Operations
  • IEST-RP-CC027Personnel in Cleanrooms
PDF

All of our standards document are available in PDF (Portable Document Format), an electronic, downloadable format.You will be able to download the file in your account downloads.

Multi-User Access

After purchasing, you have the ability to assign each license to a specific user.

Printable

At any time, you are permitted to make printed copies for your and your members' reference use.

IEST RP-DTE011.1

IEST RP-DTE011.1

Mechanical Shock and Vibration Transducer Selection..

$121.00 $242.50

IEST RP-CC026.2

IEST RP-CC026.2

Cleanroom Operations..

$153.00 $305.00

IEST RP-CC034.2

IEST RP-CC034.2

HEPA and ULPA Filter Leak Tests..

$98.00 $196.00

IEST RP-CC001.4

IEST RP-CC001.4

HEPA and ULPA Filters..

$80.00 $159.00