Cleanroom Procedure Bundle
SKU:
CLEANBNDL
$349.00
$349.00
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 BundleThe 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 - OverviewThe Cleanroom Procedure Bundle includes the following procedures:
Cleanroom Procedure Bundle - ComplianceThe 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
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Cleanroom Procedure Bundle Contents
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Cleanroom Design and Validation Procedure
$199.00
The Cleanroom Design and Validation Procedure governs the design, build and validation of cleanrooms to ensure compliance with User Requirement Specification (URS), applicable standards and regulations, and to ensure the facility is fit for its intended purpose.
- ISO 14644:2015 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Environmental Controls Procedure | ISO 13485 | FDA QSR Compliant
$149.00
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.
- ISO 14644-1:2015 Compliant
- ISO 14644-2:2015 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Controlled Environment Cleaning Procedure | ISO 13485 | FDA QSR Compliant
$49.00
The ISO 13485 Controlled Environment Cleaning Procedure provides instruction on the cleaning practices utilized in medical device manufacturing environments.
- ISO 13485 and FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download