Cleanroom Procedure Bundle

SKU: CLEANBNDL
$349.00
$349.00
Unavailable
per item
The Cleanroom Procedure Bundle includes: Cleanroom Design and Validation Procedure; Environmental Controls Procedure; and our Cleanroom Cleaning Procedure. The procedures provide valuable guidance on the cleanroom installation, validation, monitoring and controls, and routine cleanroom cleaning practices.
  • ISO 14644-1:2015 Compliant
  • ISO 14644-2:2015 Compliant
  • ISO 14644-4:2001 Compliant
  • ISO 13485:2016 Compliant
  • ​FDA QSR Compliant
  • MS Word Format
  • ​Includes Related Forms
  • ​Digital Content - Instant Download

Cleanroom Procedure Bundle

The Cleanroom Procedure Bundle includes procedures that govern; the development of a user requirement specification (URS), cleanroom design, installation, and validation (DQ,IQ,OQ,PQ); cleanroom monitoring and controls, and cleanroom cleaning practices.

Cleanroom Procedure Bundle - Overview

The Cleanroom Procedure Bundle includes the following procedures:
  • ​Cleanroom Design and Validation Procedure -The Cleanroom Design and Validation Procedure governs the design, build and validation of cleanrooms in accordance with ISO 14644-1:2015, ISO 14644-2:2015, and ISO 14644-4:2001 and other applicable standards and regulations.
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  • Environmental Controls Procedure -The Environmental Controls procedure establishes controls for personnel and gowning, monitoring plan for viable and non-viable particulate, temperature and humidity, pressure differential, bioburden, and more per ISO 14644-1:2015 and ISO 14644-2:2015.
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  • ​Controlled Environment Cleaning -The Controlled Environment Cleaning Procedure establishes routine cleanroom cleaning requirements for daily, weekly, monthly and yearly cleaning and controlled environment care.

Cleanroom Procedure Bundle - Compliance

The Cleanroom Procedure Bundle is ISO 14644-1:2015, ISO 14644-2:2015, ISO 14644-4:2001, ISO 13485:2016 and FDA 21 CFR Part 820.70 compliant.
For more information about our Cleanroom Procedure Bundle contact us at info@aplyon.com 

RELATED LINKS

Clinical Evaluation Procedure Bundle
Complaint Handling Procedure Bundle
Design Control Procedure Bundle
Document Control Procedure Bundle
Medical Device Labeling Procedure Bundle
Medical Device Software Procedure Bundle
​Risk Management Procedure Bundle

Cleanroom Procedure Bundle Contents

cleanroom design and validation procedure
Design and Validation
controlled environment cleaning
Controlled Environment Cleaning
environmental controls procedure
Environmental Controls

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Environmental Controls Procedure | ISO 13485 | FDA QSR Compliant

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Controlled Environment Cleaning Procedure | ISO 13485 | FDA QSR Compliant

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