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INSTALLATION, OPERATIONAL and PERFORMANCE QUALIFICATION PROTOCOL Installation, Operational, Performance Qualification of the [name Laminar Air Flow with location here

Validation No.XX and Asset No.XX Your Site Here

Ref: XXXX

Rev: 1

Page No 1 of 3

Protocol Approval Name Author

Responsible Your Name

Signature

Date

Signature

Date

QA Sign Off Production Sign off Regulatory Affairs Sign off (if applicable)* Engineering Sign off

Protocol Execution Approval Name Author

Responsible Your Name QA Sign Off Production Sign off Regulatory Affairs Sign off (if applicable)* Engineering Sign off

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[Description here] Here]

[ASSET Number/s

Introduction The validation document within is a combined Retrospective Installation, Operational and Performance Qualification for the [name the Laminar Air Flow here] in the [name the location] of the Your Site.[include a brief introduction of the history of the Laminar Air Flow Units here].

Brief System Description and IOPQ Rationale There are currently [name the number of Laminar Air Flow Units here with the ASSET numbers] in situation in the [name location here] ready for validation. The Laminar Air Flows are designed to meet BS5295 and ISO14644. These Laminar Air Flow units have been in use for several years but require validation. Since there is historical data (maintenance, running history, microbial tests) this will be taken into account within this validation. The Laminar Air Flow units have been designed and manufactured by [Name Manufacturer here] The LAF consist of the following: i) Module Body The module body is made of mild steel, painted and free of burrs and fully sealed using silicone sealant. ii) Work Surface The work surface is manufactured from 304 Stainless Steel with a surface finish. iii) Fan A centrifugal type with a built-in rotor motor impeller and situated in the fan chamber directly above the HEPA (High Efficiency Particulate Air) filter. The fan unit is sealed for life and should require no lubrication or maintenance under normal working conditions. It is designed to cater for the dirty condition of the main HEPA filter iv) Pre-filters The pre-filters located before the fan& in front of the HEPA filter, located behind a protection grille (or baffle) v) HEPA filters The HEPA filters is of 99.999% efficiency @ 0.3 microns to Sodium Flame Test BS 3928. This filter will provide clean air quality to E/F to BS5295 & ISO 14644 Class 5, however the environmental conditions of the cleanroom are Class 7 and 8, hence the filters demonstrate a higher than required efficiency. vi) HEPA filter sealing The main HEPA filter is located within the filter plenum silicone sealed around its periphery to form an air tight seal. vii) Controls These controls are mounted onto a membrane planel located on the front face of the control/light housing, as follows – - Power On Indication - Fan On/Off Switch - Lights On/Off Switch - UV Lights ON/Off Switch viii) Fan Speed Controller Protocol Number: : XX-IOPQ-XX Page 2 of 3

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[Description here] Here]

[ASSET Number/s

The fan speed controller is mounted onto a chassis plate which is located internally. [Write a brief paragraph explaining the Laminar Air Flow Units history, its uses, performance (check Maintenance System for breakdown/maintenance and calibration history)]. There is no documented IQ/OQ for these equipment, therefore this validation will document the gaps for Installation, Operational and Performance Qualifications.

HEPA Filter, and Fan within Main Body

Module Body Controls

Pre-filters behind grille/ baffle

Work Surface

Protocol Number: : XX-IOPQ-XX Page 3 of 3

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IOPQ Laminar Air Flow Validation Template - Sample  

Protocol Execution Approval Name Responsible Signature Date Author Your Name QA Sign Off Production Sign off Regulatory Affairs Sign off (if...