To describe a procedure for Qualification of Air Handling Unit.
This SOP is applicable for Qualification of Air Handling Unit
Assistant Engineer/Above shall be responsible for implementation and compliance of the SOP.
Manager-Engineering / Manager-Production / Head-QA shall be accountable for implementation and compliance the procedure mentioned in this SOP.
Summary sheet of Design qualification – Attachment-I
Summary sheet of Installation qualification – Attachment-II
Summary sheet of Operation and Performance qualification – Attachment-III
- DESIGN QUALIFICATION:
- During the concept study, based on the guidelines and discussion with consultant/Vendor finalize the concept of cleanliness classification, area pressurization, general and product specific temperature and RH conditions required, type of operation that will be carried out in the room.Ensure that no activities are carried out in the respective machine.
- Collect the information about equipment proposed, utility consumption, hot surfaces, specific exhaust for room, if any.
- After finalizing the conceptual architectural layout, number the rooms and prepare the URS room wise giving following details:-
- DESIGN QUALIFICATION:
- Room dimension
- Type of construction
- Cleanliness class to be maintained
- Temperature and RH to be maintained with tolerances limits
- Differential pressure to be maintained with respect to adjoining area or atmosphere
- Preferences for return air from room, i.e: Low level, ground and ceiling return etc.
- Requirements for terminal arrangement, i.e: terminal filter or grill, if terminal filter, class of filter
- Minimum number of Air changes per hour
6.1.4 Draft the URS and Send the final URS for approval of Head of the user department, and Head-QA.
6.1.5 After getting approval from user department and QA, Engineering will send the URS copies to vendors.
6.1.6 Based on URS, vendor to prepare design document in discussion with Sano Cito Therapeutics Inc.
The design document should have minimum following technical information:-
- HVAC zoning with respect to class of cleanliness
- AHU zoning (Giving rooms covered by individual AHU)
- Schematic of airflow with filtration level and pressure level
- References guidelines to be used for further detailing, performance qualification etc.
- Ducting Layout
- Location of AHU
6.1.7 Select vendors and ask them to provide DQ as per our URS.
6.1.8 Sano Cito Therapeutics Inc. representative should approve the DQ documents and generate the
purchase order with approved DQ
6.1.9 The documents generated from vendor’s end will be compiled as DQ document.
6.2 INSTALLATION QUALIFICATION:
6.2.1 Since the HVAC vendor is the principal contractor and has designed the system taking responsibility
to manufacture, supply, install the system such that the system operates and performs as per the URS
and purchase order, the inspection of individual items is responsibility of vendor. However during
Discussion if felt necessary consultant and Sano Cito Therapeutics Inc. or either of them will go for
inspection of items at the manufacture’s end. Vendor to submit his reports on testing done at
manufacturer’s site for the key items.
6.2.2 Verification on receipt at site :-
- Receipt of material at site
- Cross verification of received material for its specifications against specifications approved during Design qualification.
- Prepare verification Note (Vendor can use his standard format or can evolve format in discussion to be noted.
- Any deviations to be noted.
- Vendor to correct the deviations and verify it again.
- Approval of final verification note by consultant and / Sano Cito Therapeutics Inc. or either of them.
6.2.3 Verification of Installation:-
- The installation can start progressively as the receipt of material on site progress. The activity of verification of received material at site will continue simultaneously till the entire material is received.
- Checking of installation to be carried out with respect to details, drawings approved during Design qualification step. One copy of such approved documents to be used to check and mark the correctness of installation, describing deviations if any and corrections carried out after reporting deviations. The deviations with respect to site constraint etc. should be noted on respective drawing, with sound scientific rationale for the change and acceptance of it giving reason for acceptance.
- Prepare installation check sheets to ensure the installation checks for general engineering items like installations of gaskets between flanges, tightening of bolts etc. These check sheets can also have checks that are carried out as stated above. To have summarized statement available.
- Similar exercise to be carried out to check the electrical installations simultaneously. The drawings, details approved during Design qualification stage should be used. The check sheet for general electrical checks to be carried out.
- Check the input utilities for their locations, size etc. Verify their correctness. This can be included as part of check sheet.
- Vendor to give his standard procedure for clean down and maintenance of HVAC system. Sano Cito Therapeutics Inc. should approve the same.
- Vendor to compile calibration certificates, test certificates of all sensors, controllers, indicators, filters including HEPA etc. AHU system wise and submit it to Sano Cito Therapeutics Inc.
6.2.4 Vendor to compile all documents generated from, AHU systems and prepare IQ summary sheet
to submit it for approval of Sano Cito Therapeutics Inc.
6.2.5 The documents generated related to installation from vendor’s end will be compiled as IQ document.
6.3 OPERATIONAL AND PERFORMANCE QUALIFICATION:
6.3.1 For an HVAC system the parameters to be tested for operation qualification and performance
qualification are overlapping, it is intended to club operation and performance qualification of HVAC
6.3.2 Vendor to submit following procedures & will be examined by Sano Cito Therapeutics Inc
6.3.3 Based on operational manual supplied by vendor prepare draft operational SOP.
6.3.4 Ensure the gauges, dials, indicators etc. are calibrated before operational SOP.
6.3.5 Based on draft operational procedure, critical operational parameters and cleanliness zoning
requirements prepare Operational Qualification protocol.
6.3.6 Protocol should elaborate functional test & acceptance criteria along with room wise sampling plan for
various parameters like, temperature, humidity, pressure differential, DOP check, non-viable counts &
6.3.7 Ensure that process area supplied by respective AHU system is visually clean and access is restricted.
Ensure that requisite utility systems are operational and commissioned.
6.3.8 Start the system. Allow it to stabilize. Tune it for required differential pressure, ACH, temperature and
RH conditions & observe it initially. During this tenure necessary on the job training should be
imparted to operators.
6.3.9 On stabilization of system initiate OPQ exercise as per the protocol.
6.3.10 If the system meets the acceptance criteria, prepare the OPQ report and finalize the operational
SOP’s. Attach any raw data generated during the operation.
6.3.11 In case the acceptance criteria are not met, record & report the non-conformance.
6.3.12 Analyze the non-conformance to assess whether the non-conformance is due to manufacturing of the
system, utilities or errors in the operational SOP or error in operation.
6.3.13 In case of system malfunctioning vendor to take corrective action & offer system for operating trail.
Repeat the OPQ exercise and also organize training to operators accordingly.
6.3.14 In case of malfunctioning of utilities, engineering to take corrective action & offer system for
6.4 All critical equipment and systems procured after effective date of this SOP should be qualified
as per the procedure given in this SOP.
6.5.1 Periodic re-qualiﬁcation of parameters should be done every year. Tolerance for periodic review is ±2 months.
6.5.2 Re-qualiﬁcation should also be done when any change, which could affect system performance, takes place.
SOP: Standard operating procedure.
QA: Quality Assurance department.
HVAC: Heating Ventilation and Air Conditioning.
AHU: Air Handling Unit.
DOP: Dispersed oil Particulate.
ACH: Air Changes per Hour.
- DISTRIBUTION LIST:
10.0 HISTORY OF REVISION:
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