Learn how to perform the Incubator Performance Qualification (PQ) of a laboratory incubator in pharmaceutical microbiology. This guide covers the qualification procedure, acceptance criteria, documentation requirements, and GMP best practices to ensure reliable and compliant incubator performance.
TABLE OF CONTENT
| PARTICULARS | PAGE NO. |
| Objective | |
| Scope | |
| Qualification Schedule | |
| Location of Equipment | |
| Validation Team and Responsibility | |
| Pre-approval of documents | |
| Scope of supply | |
| Brief process description | |
| Performance qualification procedure | |
| Performance verification | |
| Performance qualification report | |
| References | |
| Result | |
| Deviation/change control | |
| Summary | |
| Conclusion | |
| Post approvals |
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Purpose of Incubator Performance Qualification
The purpose of this protocol is to establish documented evidence that the equipment/system is installed, operated, and performs in accordance with predefined specifications and regulatory requirements.
To demonstrate and document that the microbiology laboratory incubator consistently maintains the specified temperature under routine operating conditions and is capable of supporting microbiological testing activities as intended. This qualification provides documented evidence that the incubator performs reliably within predefined acceptance criteria during normal use.
Scope
This protocol applies to the Performance Qualification of the microbiology laboratory incubator installed at the manufacturing facility. It covers temperature performance verification under loaded and unloaded conditions, temperature recovery following door opening, alarm verification (where applicable), and evaluation of operational consistency during routine laboratory use.
Qualification Schedule
Performance Qualification shall be performed after successful completion and approval of:
- Design Qualification (DQ), where applicable
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Calibration of all critical measuring instruments
PQ shall also be performed:
- After major repairs or modifications
- Following relocation of the equipment
- Following software upgrades affecting performance
- As part of requalification, if required by site procedures
Frequency
Performance check of the machine should be re-qualified after every 5years ±2 months.
Location of Equipment
The location of the equipment in Microbiology Department at XYZ company.
| Name of Equipment | ID No. | Room Name | Section |
| Incubators | Incubator Room | Microbiology Department |
Validation Team and Responsibility
| Department | Responsibility |
| Engineering | Preparation of protocol and compilation of report. Review of protocol and report. Execution of Qualification activities with the user/ concern departments per the protocol. Responsible for the compliance of qualification data |
| Quality Control | Review of protocol and report.Execution of qualification activities as per the protocol |
| Quality Assurance | Review, approval and certification of the protocol / reports. Execution& approved of qualification activities as per the protocol & certification after successful qualification of equipment. Responsible for the compliance of qualification data |
Pre Approval of Documents
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Checked By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Quality Control |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
Scope of supply:
| Description | Specification |
| Make | |
| Model/ Serial No. | As per cGMP model (Serial no.1892,1893,1980) |
| Control system | 230 /240 volts |
| Insulated chamber | |
| Stainless steel shelves | |
| Digital temperature controller | |
| Temperature sensor | |
| Air circulation system | |
| Display panel | |
| Door gasket | |
| Alarm system (if applicable) | |
| Power supply unit |
Brief process description for Incubator Performance Qualification:
| Sr. No. | Test | Procedure | Acceptance criteria |
| Verification of Temperature Stability | Operate the incubator at the specified operating temperature. | Temperature remains within ±1.0°C of the set value throughout the monitoring period. | |
| Temperature Uniformity | Place calibrated temperature probes at representative locations within the chamber. Record temperatures at predetermined intervals. | Temperature variation between locations shall not exceed the approved validation limit. | |
| Loaded Chamber Performance | Load the incubator with representative microbiological media or simulated load. Monitor chamber temperature for the qualification period. | Chamber temperature remains within specified operating limits. | |
| Door Opening Recovery Test | Open the incubator door for approximately one minute. Close the door and monitor recovery time. | Chamber temperature returns to the specified operating range within the predefined recovery time. | |
| Continuous Operation Test | Operate the incubator continuously for not less than 24 hours under normal operating conditions. | Stable temperature maintained without interruption. No abnormal alarms or equipment malfunction observed. | |
| Alarm Verification | High temperature alarm Low temperature alarm Sensor failure alarm (where applicable) | Alarm activates at predefined limits. Audible and visual alarms function correctly. |
Temperature Mapping (Empty Chamber Study) for Incubator Performance Qualification
Calibrated temperature probes shall be placed inside the chamber at the four corners (top left, top right, bottom left, and bottom right) and at the center, with additional positions selected based on the chamber volume.
Incubators shall be set at their respective operating temperature ranges of 20–25°C, 30–35°C, and 42–44°C and allowed to stabilize for at least 1–2 hours.
The temperature shall then be recorded at 1-minute intervals for 24 hours and the minimum, maximum, and average temperatures shall be documented. No Deviation should be observed during Performance Qualification.
Acceptance Criteria:
Temperature within ±1°C (or as per specification)
Uniformity within defined limits (e.g., ≤2°C variation across chamber)
Temperature Mapping (Loaded Chamber Study) for Incubator Performance Qualification
Place simulated load inside chamber (media bottles with water).
Repeat mapping procedure as above.
Record and analyze data.
Acceptance Criteria:
Same as empty chamber unless otherwise specified.
Recovery Time Test:
Stabilize incubator at set temperature.
Open door for defined time (e.g., 2 minutes).
Close door and record time taken to return to set temperature.
Acceptance Criteria:
Recovery within predefined time (e.g., ≤15 minutes).
Alarm Verification
Set the high and low temperature limits of the incubator and intentionally create a temperature deviation to trigger the alarm system. Verify that the audible and visual alarms are activated properly and confirm that the remote alert system functions correctly, if applicable.
Incubator Performance Qualification/Verification
Performance Verification is carried out to confirm that the equipment/system consistently performs according to predefined specifications during routine operating conditions. All critical parameters shall be tested, recorded, and evaluated against established acceptance criteria.
Standard Operating Parameters Verification
To verify the standards operating procedure required in the qualification of Incubators shall be of current version.
| Required SOP |
| Operation and calibration of bacteriological incubator |
| Operation and calibration of BOD incubator |
| Calibration of Instruments |
| Preventive Maintenance program for all Machines &Equipment’s |
| Validation and Re-Validation |
Calibration of all measuring Instruments
Verify the calibration of all the measuring instruments used during qualification of Incubators as mentioned below.
| Description |
| Calibrated Digital Thermometer |
| Calibration of All Measuring Instruments |
| Calibration of All Measuring Instruments as per Applicable Standards and SOPs |
| Calibration of temperature sensor |
Observations & Results
Ensure calibration of the instruments used to test validation parameters during qualification of Incubators are in valid period& record the calibration details
| Instrument Name | ID no. | Calibrated on | Calibration due on | Calibration report No. |
Checked By (Sign & Date): __________________
Procedure For Incubator Performance Qualification Study
- Clean the outer surface and inner chamber of the incubator with lint-free cloth wiped with 70% v/v IPA before use.
- Ensure the incubator is placed on a stable surface and properly connected to power supply.
- Switch “ON” the mains power supply.
- Switch “ON” the incubators and set the required temperature (Incubators I.D. No. 20-25°C,30-35°C and 42-44°C or as per study requirement).
- The following procedure shall be followed for conducting the Performance Qualification (PQ) study of the equipment/system:
- Allow the incubator to stabilize for at least 1–2 Hours before placing samples inside.
- Record the set temperature and actual displayed temperature in the logbook.
- Place calibrated temperature data loggers/sensors at different locations (top, bottom,
- center, front, back) for study purpose.
- Close the door properly to avoid temperature fluctuation.
- Record temperature at defined intervals (e.g., every 30 minutes or as per protocol).
- Monitor and record any alarm or deviation during the study.
- Do not open the door frequently during the study period.
- After completion of study, remove samples and data loggers carefully.
- Wipe the inner chamber with 70% v/v IPA.
- Switch “OFF” the incubator if not in use.
- Close the incubator door properly.
Preparation
- Ensure IQ and OQ are completed and approved.
- Verify that all measuring instruments have valid calibration status.
- Review and approve the PQ protocol before execution.
- Ensure SOPs and test formats are available.
- Clean the equipment and surrounding area.
Execution of Tests
Perform all predefined performance tests as per the approved protocol, such as.
- Clean and empty incubator.
- Place calibrated sensors inside.
- Set required parameters (e.g. 30-35°C, 20-25°C and 42-44°C).
- Allow stabilization period (at least 1–2 hours).
- Record readings at regular intervals.
- Analyze data and compare with acceptance criteria.
- Document results and issue validation report.
Cleaning of Incubators:
- Keep the Incubators interior and exterior free from dust.
- Before starting work, clean with 70 % IPA/disinfectant using lint free cloth.
- Inside cleaning of Incubators is recommended before starting any work, after working in the cabinet, in the event of spillage.
Alarm and Safety Precautions
- Over-temperature alarm
- Door-open alarm
- Power failure alarm
- Sensor failure detection
- Backup system (if installed)
Performance qualification report:
_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
References:
WHO Good Manufacturing Practices
EU GMP Guide, Annex 15 – Qualification and Validation
Result:
The incubator shall be considered satisfactory if all Performance Qualification tests comply with predefined acceptance criteria without unresolved deviations.
Deviation/Change Control
Any deviation observed during execution shall be documented according to the site deviation management procedure.
Changes affecting qualified status shall be managed through the approved Change Control System and assessed for impact before implementation.
Summary:
Performance Qualification activities confirm that the microbiology laboratory incubator consistently performs according to its intended operational requirements under routine laboratory conditions. All recorded observations, test data, and verification activities shall support the qualified status of the equipment.
Conclusion:
Based on successful completion of all qualification tests and satisfactory review of recorded data, the microbiology laboratory incubator is considered suitable for routine microbiological testing activities and may be released for intended use.
Post Approval of Documents
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Checked By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Quality Control |
Approved by
| Designation | Name | Date | Signature |
| Head QA |