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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The Environmental Controls Procedure establishes cleanroom controls and monitoring requirements for cleanroom or controlled manufacturing environment use and attributes that affect cleanroom performance. ​The procedure establishes personnel controls and gowning, monitoring plan development for viable and non-viable particulate, temperature and humidity, pressure differential, bioburden, etc., including testing apparatus to be used, locations and frequency, baseline data, data trending, action and alert levels, and the application of risk assessment tools.
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Controlled Environment Cleaning Procedure | ISO 13485 | FDA QSR Compliant

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