Objective of URS for Autoclave
Autoclave is a critical equipment used in pharmaceutical and microbiology laboratories for sterilization of materials. Proper sterilization is essential to ensure product quality, safety, and compliance with GMP requirements. This document describes the URS for Autoclave a 300 Liter Fully Automatic Autoclave intended for laboratory and pharmaceutical applications.
Table of Content
| Description | Page No. |
| Introduction | |
| Purpose& Scope | |
| Responsibility | |
| User Requirement Specification | |
| Abbreviations | |
| References (If Any) | |
| Documents Attached | |
| Scope Of Supply | |
| Approval |
Purpose & scope:
The purpose of this User Requirement Specification (URS) is to define the operational, functional, and technical requirements for the procurement, installation, qualification, and operation of a 300 Liter Fully Automatic Autoclave.
Scope:
This URS is applicable to the Fully Automatic Autoclave to be installed in the Microbiology / QA / QC / Production laboratory for sterilization of media, glassware, instruments and accessories.
Responsibility:
The User Requirement Specification group comprising of representatives from each of the following departments shall be responsible for the overall compliance of the document.
| Department | Responsibilities |
| QA | To ensure the user requirement specification document and related activity. To approve the user requirement specification. To evaluate the Autoclave compatibility of environment. |
| QC | To prepare and Review the URS |
URS for Autoclave:
Equipment/System Description:
The Fully Automatic Autoclave is a steam-based sterilization equipment designed for effective sterilization of laboratory materials such as media, glassware, instruments, garments. The equipment operates on the principle of saturated steam under pressure to achieve the desired sterilization temperature and holding time.
The system shall consist of a 300-liter stainless steel chamber (SS 316L) with a fully automatic PLC-controlled operation and HMI touch screen interface for monitoring and control of temperature, pressure, and cycle time. The outer body shall be constructed of SS 304 with adequate insulation to minimize heat loss and ensure operator safety.
The autoclave shall be equipped with automatic water filling, air purging, sterilization, exhaust, and drying functions. The equipment shall include safety features such as door interlock system, over-temperature protection, over-pressure protection, safety relief valve, and emergency stop button.
The system shall support multiple pre-programmed sterilization cycles and allow user-defined programs with data logging capability. The equipment shall be suitable for GMP-compliant pharmaceutical and microbiology laboratory applications and shall be supplied with complete documentation, validation support, and standard accessories.
Technical Specification
| Equipments Name | Autoclave |
| Autoclave Capacity | 300 Liter |
| Type | Vertical / Horizontal (As per Requirement) |
| Outer Body Material | Material: SS 304 Corrosion Resistant with Smooth Finish |
| Door | Type: Double Door Operation: Automatic / Semi-Automatic Door Interlock: Electro-Mechanical Safety Interlock Gasket: Silicone Rubber, High Temperature Resistant |
| Controlled system | PLC Based Control Panel Minimum 7-inch HMI Touch Screen Password Protected Access Levels Digital Display of Temperature, Pressure & TimeData Logging Facility with USB / Printer Port |
| Sterilization Parameter | Temperature Range: 105°C – 134°CPressure Range: 15 – 30 PSITimer Range: 1 – 99 MinutesTemperature Accuracy: ±1°CPressure Accuracy: ±1 PSI |
| Chamber | Material of Construction: SS 316LCapacity: 300 LitersSurface Finish: Mirror / Electro PolishedShape: Cylindrical / RectangularWorking Pressure: Up to 30 PSIWorking Temperature: Up to 134°C |
| Safety Features | Over-Temperature ProtectionOver-Pressure ProtectionLow Water Level Cut-OffSafety Relief ValveEmergency Stop ButtonAudio-Visual Alarm SystemAutomatic Exhaust Control |
| Utilities Requirements | Power Supply: 415 V ±10%, 50 Hz, 3 PhaseWater Supply: RO / DM WaterDrain Line: RequiredSteam Source: Inbuilt / ExternalCompressed Air: If Applicable |
| Accessories | SS Trays – Minimum 3 Nos.SS Basket / StandSilicone Door GasketDrain ValveLoading / Unloading Trolley (Optional) |
| Compliance | GMP / GLP CompliantCE / ISO CertifiedIQ / OQ / PQ Documentation Support Required |
Operational Requirement of URS for Autoclave:
Fully Automatic Autoclave shall be designed for safe, reliable, and user-friendly operation with minimal manual intervention. The system shall ensure consistent sterilization performance and shall be suitable for continuous laboratory use.
Operational Requirements shall include:
- Fully automatic operation controlled through PLC with HMI Touch Screen Interface.
- Pre-programmed sterilization cycles for Liquid, Solid, and Glassware.
- Provision for user-defined/custom programs with minimum 10 recipe storage capacity.
- Automatic water filling, air purging, sterilization, exhaust, and drying functions.
- Real-time display of temperature, pressure, and cycle time on HMI.
- Password-protected user access levels to prevent unauthorized changes.
- Automatic alarm and fault indication in case of deviation or system error.
- Data logging facility for cycle records with USB/Printer output option.
- Cycle completion audio-visual alert.
- Door shall remain locked during the sterilization cycle and open only after safe pressure release.
- System shall be capable of continuous operation for multiple cycles per day without performance degradation.
Quality and Process Instruments:
The Fully Automatic Autoclave system shall be equipped with calibrated and high-accuracy quality and process monitoring instruments to ensure reliable sterilization performance and compliance with GMP requirements.
The following instruments shall be provided:
- Temperature Sensor: PT-100 RTD type with high accuracy for chamber temperature monitoring.
- Digital Temperature Controller/Indicator: For continuous display and control of sterilization temperature.
- Pressure Gauge: Analog and Digital type for real-time chamber pressure monitoring.
- Pressure Transmitter/Sensor: Integrated with PLC for automatic control and alarms.
- Timer / Cycle Controller: Programmable sterilization holding time control.
Environment for Equipment:
The Fully Automatic Autoclave shall be suitable for installation and operation in a controlled laboratory / pharmaceutical environment. The equipment shall be designed to operate efficiently under the following environmental conditions without affecting performance, safety, or accuracy.
Environmental Requirements:
- Installation Area: Indoor laboratory / clean utility area
- Ambient Temperature: 20°C to 30°C
- Relative Humidity: 40% to 60% RH (Non-Condensing)
- Room Ventilation: Adequate ventilation or exhaust system shall be available to dissipate heat and steam.
- Floor Condition: Leveled, vibration-free, and load-bearing floor surface.
- Cleanliness: Dust-free and dry environment.
- Lighting: Adequate illumination for operation and maintenance activities.
- Drainage Facility: Proper floor drain shall be available near the equipment.
- Electrical Environment: Stable power supply with proper earthling and dedicated MCB/Isolator.
- Space Requirement: Sufficient clearance shall be available around the equipment for safe operation, cleaning, and preventive maintenance.
- The equipment shall not be exposed to corrosive vapors, excessive moisture, or direct sunlight
Desired Output:
The Fully Automatic Autoclave shall consistently deliver effective and reproducible sterilization results ensuring complete for all defined sterilization cycles.
The desired outputs of the equipment shall include:
- Achievement of validated sterilization temperature and pressure for the defined holding time in each cycle.
- Uniform temperature distribution within the chamber during sterilization.
- Successful sterilization of media, glassware, instruments and garments without material damage.
- Cycle completion confirmation with audio-visual indication.
- Digital cycle reports including date, time, temperature, pressure, and cycle duration.
- Biological Indicator and Chemical Indicator pass results during validation runs.
- No steam leakage, pressure drop, or operational deviation during the cycle.
- Repeatable and reliable performance for consecutive sterilization cycles.
The output shall comply with internal quality standards and applicable GMP guidelines, ensuring safe and effective sterilization for routine laboratory and pharmaceutical operations.
Read also => User Requirement Specification for Sonicator
Testing:
The Fully Automatic Autoclave shall undergo necessary testing and verification to ensure compliance with defined technical, operational, and safety requirements prior to acceptance and routine use.
Testing requirements shall include:
- Factory Acceptance Test (FAT):
Verification of equipment design, construction, control system functionality, alarms, and safety interlocks at vendor site. - Site Acceptance Test (SAT):
Verification of installation, utilities connection, and operational performance at user site. - Installation Qualification (IQ):
Confirmation of correct installation as per approved drawings and specifications. - Operational Qualification (OQ):
Verification of operational parameters such as temperature, pressure, timer accuracy, alarms, and control functions. - Performance Qualification (PQ):
Verification of sterilization effectiveness using Biological Indicators (BI) and Chemical Indicators (CI) under actual load conditions. - Temperature Mapping Study:
To confirm uniform temperature distribution inside the chamber. - Leak Test / Pressure Hold Test:
To ensure chamber integrity and absence of steam leakage. - Calibration Verification:
Calibration of temperature sensors, pressure gauges, and controllers traceable to national standards.
The equipment shall be accepted only after successful completion and documentation of all above tests as per GMP requirements.
Safety Requirement:
The Fully Automatic Autoclave shall be designed with adequate safety features to protect the operator, equipment, and sterilized materials during normal and abnormal operating conditions. The system shall comply with applicable safety and GMP guidelines.
Protection:
- Over-Temperature Protection: Automatic cut-off in case temperature exceeds set limits.
- Over-Pressure Protection: Safety relief valve and automatic pressure control system.
- Door Interlock System: Door shall not open during sterilization or when chamber pressure is above safe limit.
- Low Water Level Protection: Automatic heater cut-off to prevent dry heating.
- Thermal Insulation: Outer surface temperature shall remain within safe limits to prevent operator injury.
- Electrical Protection: Proper earthling, MCB/ELCB protection, and short-circuit safeguards.
Alarms and Warning:
The system shall provide audio-visual alarms and on-screen warnings for abnormal or fault conditions, including but not limited to:
- High Temperature Alarm
- High Pressure Alarm
- Low Water Level Alarm
- Door Not Locked Alarm
- Cycle Failure / Deviation Alarm
- Sensor Failure Alarm
Emergency Stop:
A clearly visible and easily accessible Emergency Stop (E-Stop) push button shall be provided on the control panel to immediately stop the cycle and isolate power to critical components during emergency conditions.
Power failure:
- In case of power failure, the system shall automatically stop the cycle in a safe mode.
- Door shall remain locked until chamber pressure and temperature reach safe levels.
- System shall have auto-resume or safe restart provision after power restoration.
- Cycle data shall be stored in memory to prevent data loss.
- No unsafe steam release or uncontrolled pressure drop shall occur during power interruption.
These safety provisions shall ensure safe operation, prevent accidents, and maintain equipment integrity under all operating conditions.
Documents Required of URS for Autoclave:
Vendor shall submit Functional Specifications, Installation Qualifications, Operational Qualifications, and Performance Qualifications.
ABBREVIATION:
URS: User Requirement Specification
cGMP : current Good Manufacturing Practices
PLC: Programmable Logic Controller
HMI: Human Machine Interface
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
QC: Quality Control
QA: Quality Assurance
OC: Degree Celsius
SCOPE OF SUPPLY:
The scope of supply shall include the following for the Fully Automatic Autoclave–
- 300 Liter Fully Automatic Autoclave
- Control Panel with PLC & HMI
- Standard Accessories (Trays, Basket, Gasket)
- Installation and Commissioning
- IQ, OQ, PQ Documentation
- Training to Operators
- Warranty and After-Sales Support
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