Installation Qualification of Autoclave is GMP qualification activity performed to verify that the autoclave is installed correctly as per approved design specifications, manufacturer recommendations, and pharmaceutical requirements. It confirms equipment installation, utility connections, instruments, safety features, and documentation before proceeding to operational qualification.
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TABLE OF CONTENT
| PARTICULARS | PAGE NO. |
| Title page | |
| Table of content | |
| Objective | |
| Scope | |
| Pre approval of documents | |
| Scope of supply | |
| Brief process description | |
| Technical specification | |
| Technical specification of the components | |
| Required utilities | |
| Installation qualification procedure | |
| Safety features & alarm | |
| Post approval of documents | |
| List of abbreviations |
Objective of Installation Qualification of Autoclave
To verify and document that the Vertical Autoclave – 600 Liter is installed correctly as per manufacturer specification, GMP requirements, and approved layout, and is ready for Operational Qualification.
Purpose
The scope of this qualification document is to verify the installed components as described in IQ.
This document is applicable for Vertical Autoclave – 600 Litres located at XYZ company.
PRE APPROVAL OF DOCUMENTS
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Quality Control | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
Supply Sources including Installation Qualification of Autoclave
| Description | Specification |
| Make | |
| Model/Serial No. | As per cGMP model |
| Control system | 230 V AC Single Phase |
Procedure Description
The Vertical Autoclave is used for discard of microbiological media, culture, and waste by applying saturated steam under pressure at predefined temperature and time cycles.
Technical Specification concludes Installation Qualification of Autoclave
| Parameter | Specification Requirement |
| Equipment Name | Steam Sterilizer / Autoclave |
| Application | Sterilization of equipment, utensils, glassware, media, and components |
| Type | Vertical / Horizontal / Pass-through Autoclave |
| Chamber Material | SS 316 / SS 316L Stainless Steel |
| Jacket Material | SS 304 / SS 316 (as applicable) |
| Chamber Volume | As per requirement (e.g., 100 L, 200 L, 500 L, etc.) |
| Operating Temperature | 121°C – 134°C (typical) |
| Operating Pressure | Approx. 1.1–2.2 bar (depending on cycle) |
| Design Pressure | As per applicable standard |
| Temperature Accuracy | ±1°C or as specified |
| Temperature Sensor | Calibrated RTD / Thermocouple |
| Control System | PLC-based automatic control system |
| Display | Touch screen HMI with cycle parameters |
| Sterilization Cycle | Pre-vacuum / Gravity / Drying cycle |
| Vacuum System | Vacuum pump / Venturi system (as applicable) |
| Steam Supply | Clean steam / plant steam (as required) |
| Air Removal | Vacuum pulse / gravity displacement |
| Door Type | Hinged / Sliding / Automatic door |
| Door Safety | Pressure interlock and safety locking system |
| Piping Material | SS 316L |
| Valves | Pneumatic sanitary valves |
| Pressure Gauge | Digital/Analog calibrated gauge |
| Recording System | Batch report / data logging system |
| Alarm System | High temperature, pressure, cycle failure alarms |
| Drain System | Condensate drain arrangement |
| Surface Finish | Internal mirror finish (typically Ra ≤ 0.8 µm) |
| Electrical Supply | As per site requirement |
| Qualification Requirement | DQ, IQ, OQ, PQ |
| Compliance | GMP, ASME/PED (as applicable) |
Utilities required during Installation Qualification of Autoclave
| Utility | Requirement / Specification |
| Electrical Power Supply | As per equipment requirement (e.g., 415V AC, 3 Phase, 50 Hz or site standard) |
| Clean Steam Supply | Required for sterilization cycle; quality as per GMP requirement |
| Plant Steam (if applicable) | For jacket heating or non-product contact applications |
| Water Supply | Purified Water / Soft Water supply as per process requirement |
| Cooling Water | Required for condenser and cooling cycle (if applicable) |
| Compressed Air | Oil-free instrument air for pneumatic valves and controls |
| Vacuum Supply | Vacuum pump/system for pre-vacuum and air removal cycle |
| Drain System | Floor drain/closed drain connection for condensate and effluent discharge |
| HVAC Requirement | Controlled environment with suitable temperature, humidity & pressure conditions |
| Exhaust/Vent | Sterile venting arrangement with suitable filtration (if required) |
| Data & Communication | Ethernet/LAN connection for monitoring, SCADA/BMS integration |
| Earthing | Proper electrical grounding connection |
| Compressed Air Quality | Dry, clean, and filtered instrument air as per GMP requirement |
Procedure for Installation Qualification of Autoclave
Pre-Installation Document Review
- Verify approved documents:
- User Requirement Specification (URS)
- Design Qualification (DQ)
- Equipment specification
- Approved drawings/layout
- Manufacturer manual
- Confirm availability of required certificates.
Equipment Identification Verification
- Check equipment name, model number, serial number, and manufacturer details.
- Verify equipment against approved purchase specifications.
- Record equipment identification details.
Physical Installation Inspection
- Verify:
- Correct installation location
- Equipment orientation
- Leveling and alignment
- Foundation/support condition
- Accessibility for operation and maintenance
- Check equipment external and internal condition.
Material Verification
Verify material of construction:
- Sterilization chamber
- Jacket
- Product contact parts
- Piping and fittings
Review material certificates (MOC).
Utility Verification
Check and document connected utilities:
- Electrical supply
- Clean steam supply
- Compressed air
- Water supply
- Drain connection
- Vacuum connection (if applicable)
Instrument and Component Verification
- Temperature sensors
- Pressure sensors
- Pressure gauges
- Valves
- Filters
- Safety devices
- Door interlock system
Check calibration status of instruments.
Control System Verification
- Verify PLC/HMI installation
- Check software version
- Verify display and control functions
- Confirm alarm and interlock settings.
Safety Feature Verification
- Emergency stop function
- Door safety interlock
- Pressure protection system
- Over-temperature protection
- Pressure relief arrangement
Document Review and Recording
- Record all observations in IQ checklist.
- Attach supporting documents.
- Document deviations, if any.
IQ Completion Approval
- Review completed IQ protocol.
- Resolve deviations.
- Obtain approval from QA and concerned departments.
Acceptance Criteria:
The autoclave shall be considered successfully installed when all components, utilities, instruments, and safety features comply with approved specifications and IQ requirements.
SAFETY FEATURE & ALARM
| Safety Feature | Description |
| Door Safety Interlock | Prevents door opening when chamber is under pressure or high temperature |
| Pressure Locking System | Ensures chamber door remains locked during sterilization cycle |
| Emergency Stop (E-Stop) | Allows immediate shutdown during abnormal conditions |
| Pressure Relief Valve | Protects chamber from overpressure conditions |
| Over Temperature Protection | Prevents operation beyond the set temperature limit |
| Low Water Protection | Prevents heating operation when water level is insufficient (if applicable) |
| Steam Safety Valve | Provides protection against excessive steam pressure |
| Burst Disc / Rupture Disc | Provides additional pressure safety protection |
| Automatic Shutdown | Stops cycle during critical failures |
| Electrical Protection | Includes MCB/MCCB, overload protection, and proper earthing |
| Anti-Scalding Protection | Prevents operator exposure to hot surfaces/steam |
| Cooling Interlock | Prevents door opening until safe temperature is achieved |
| Alarm | Purpose |
| High Temperature Alarm | Alerts when chamber temperature exceeds set limit |
| High Pressure Alarm | Indicates abnormal pressure rise |
| Low Pressure Alarm | Indicates insufficient pressure condition |
| Cycle Failure Alarm | Indicates unsuccessful sterilization cycle |
| Door Not Locked Alarm | Indicates improper door locking |
| Door Open Alarm | Alerts if door is opened during operation |
| Low Water Level Alarm | Prevents dry heating condition |
| Steam Supply Failure Alarm | Indicates insufficient steam supply |
| Compressed Air Failure Alarm | Indicates pneumatic system failure |
| Power Failure Alarm | Alerts interruption of electrical supply |
| Sensor Failure Alarm | Indicates temperature/pressure sensor malfunction |
| Vacuum Failure Alarm | Indicates vacuum generation failure (if applicable) |
Post Approval
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Quality Control | |||
| Head Warehouse | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
Abbreviations Used
| IQ | Installation Qualification |
| QA | Quality Assurance |
| SOP | Standard Operating Procedure |
| URS | User Requirement Specification |
| GMP | Good Manufacturing Practice |
| PSI | Pound per Square Inch |
| MCB | Miniature Circuit Board |
| ISO | Indian Standardized Organisation |
| GMP | Good Manufacturing practices |
| MM | Millimetre |
| GA | General arrangement |
| V | Voltage |
| AC | Alternate Current |
| PID | Proportional Integral Derivative |