Objective of URS for Walk in Stability Chamber:
- This document is generating under the authority for the purpose of specifying the user requirement for Walk in stability Chamber. The User Requirements Specification (URS) is provided to define the important components, variables and options necessary for the Supplier to provide a functional of Walk in stability Chamber that meets the needs in the most cost-effective method possible. The URS is also provided to the Supplier to provide a price quote for the supply for Walk in stability Chamber including the design, Performance and manufacture of the equipment.
- The Walk in stability Chamber will be interfaced to the output and will be located in a designated operating area & will comply as per GMP operations
Table of Content of URS for Walk in Stability Chamber:
| Description |
| Title page |
| Table of contents |
| Approval of Documents |
| Objective |
| Scope |
| Location of equipment |
| Communication |
| Applicable codes and standard |
| System/equipment/instruments details |
| Scope of supply |
| Brief system description |
| Technical specification |
| Safety features |
| List of Abbreviations |
Approval of Documents of URS for Walk in Stability Chamber :
Prepared by:-
| Name | Designation/Department | Signature | Date |
| Executive/Quality Assurance |
Reviewed by:-
| Name | Designation/Department | Signature | Date |
| Manager/Quality Control | |||
| Manager/Production | |||
| Manager/Engineering |
Approved by:-
| Name | Designation/Department | Signature | Date |
| Manager/Quality Assurance |
Scope:
- The scope of this document is to define the requirements of the Walk in stability Chamber in Company.
Location of equipment:
- The Supplier shall deliver the equipment to company.
- Machine will be installed in the Stability Room
Applicable Codes and Standards: –
- The entire Supplier’s work shall comply with all relevant Indian and International Standards and Codes of Practice.
- The Supplier shall confirm all the Standards which have been used for the design and manufacture of the equipment.
System/equipment/Instruments details:
| Name of the equipment | Walk in stability Chamber |
| Capacity | 20 Kl approx. |
| Model/Type | As per GMP model |
Scope of Supply of URS for Walk in Stability Chamber:
| Type of Device | Walk in stability Chamber |
| Machine Standard | The current state of the art GMP Compliance. European medicine agency (EMA) and WHO, Regulations compliance. |
| Machine design standard for safety | The European machinery Directive 2006/42/EC. The European low voltage Directive 2014/35/EUISO/TR 12100:1992 safety machinery (Basic Concepts, general Principle of design), part 1&2.ISO 15534:2000 Ergonomic design for the safety of machine ISO 13849-1:1999 Safety machinery- safety related parts of control system. ISO 13850:1996 safety of machinery- Emergency stops principle of design. ISO 13852:1996 safety of machinery -safety distance to prevent danger zones being reached by upper limbs. ISO 13853:1996 safety of machinery safety distance to prevent danger zones being reached by lower limbs |
| Room Condition | Room Temperature: – NMT 25 degree Celsius. |
| Features | Design conforming to cGMP standards Contact part SS 316 and noncontact parts SS 304.Simple and Convenient operation, Ease to maintenance. Easy cleaning designed with easy removal weight adjustment sector.AC Frequency drive for motor |
| Document & Certificate | Manuals and Maintenance Instructions Operator manual Installation and assembly instructions for all devices. User’s manuals for all components. Trouble shooting guide. Maintenance Manual. Safety instruction. Training documentation. Electrical and Control diagrams Circuit diagrams Cable list. Single line drawing for electrical distribution. Equipment location drawing for electrical equipment and instruments. |
| Qualification Protocols | DQ Protocols and reports. FAT protocol and report. SAT protocol and report IQ protocol and report OQ Protocol and report Vendor should organize for Execution of IQ, OQ and support for PQ |
| Training | Vendor should impart necessary Operational training to user department and maintenance training to maintenance department. |
| Test, Calibration, MOC Certification | All test certificate for brought items will be provides during FAT with FAT Documents MOC Certificate will be providing during FAT with FAT documentsCalibration certificate provide for gauge during FAT. |
Brief system description of URS for Walk in Stability Chamber :
Stability chamber is a specialized machine used to test how products react to different temperature and humidity levels. It helps to determine a product’s shelf life, quality, and durability under controlled environmental condition. Stability chamber is a specially designed machine used to simulate different environmental conditions such as temperature and humidity with high accuracy. It helps test how products react over time under controlled climate settings. Also known as stabilization chambers, they are widely used to check the shelf life and durability of products like pharmaceuticals, electronics, and building materials. These chambers allow users to set specific conditions to see how products perform in various climates without having to physically visit those regions.
The basic principle of a stability chamber is to maintain consistent environmental conditions (usually temperature and humidity) for extended periods while exposing products to these controlled environments. The chamber’s conditions simulate real-world environmental factors that a product may face during its storage and use.
- Temperature Control
Stability chambers have heating and cooling systems (typically using refrigeration cycles or heaters) to maintain constant temperature ranges, as the user specifies.
The typical temperature ranges for testing could be 25°C, 30°C, 40°C, or higher, depending on the product and regulatory guidelines (such as ICH guidelines in the pharmaceutical industry).
Sensors continuously monitor the temperature inside the chamber, and adjustments are made to maintain the desired set point.
- Humidity Control
Humidity control systems ensure that the chamber maintains a specified relative humidity (RH) level.
To increase humidity, water vapour is injected into the air inside the chamber. Conversely, to reduce humidity, dehumidifiers or refrigeration systems condense moisture out of the air.
Stability chambers typically operate at RH levels such as 40%, 60%, or 75%, depending on the testing requirements.
- Uniformity
The chamber must maintain uniform conditions throughout the space. This is critical because any variation in temperature or humidity could affect the results of the stability test.
To ensure uniformity, stability chambers use air circulation systems (fans, blowers) to evenly distribute air throughout the chamber, so the conditions remain consistent at all points inside.
- Sensors and Monitoring
Stability chambers are equipped with sensors that continuously monitor both temperature and humidity.
Data logging systems are also integrated, which record the environmental conditions over time, ensuring the test parameters are maintained and allowing for later analysis of the data.
- Alarms and Safety Mechanisms
Stability chambers include alarms that notify operators if the conditions inside deviate from the set parameters, allowing for quick corrective action to be taken.
Backup systems may also be included to maintain conditions in case of a power failure or system malfunction.
The basic construction of the machine consists of:
Standard stainless steel 304 straight profile machine housing.
Technical Specification of URS for Walk in Stability Chamber :
| Particulars | Specification |
| Name | Walk in Stability Chamber |
| Capacity | 20 Kl approx. |
| Model/Type | As per GMP model |
| Size | 3000(L) X3000(W) X 2200(H) approx. |
| No. of Racks | 2 to 3approx. |
| Chamber Condition | 30º C temp. &75% RH |
| Control system | HMIDoor access systemControl Panel |
| Standby system | For refrigeration For humidity |
| Insulation | 80 mm thick PUF |
| Lights | LED Tube |
| Software | Desktop based communication software for data management |
| Utility Requirement | 1 Phase230 V50 Hz |
| Identification | Details of Make, Name, Serial No., Capacity, Model and Year of manufacture should be available. |
Safety Features:
| Critical Variables | Acceptance Criteria | Reference |
| MCB | MCB is provided so that when there is an overload in current or any short circuit then the MCB trips. | Safety Requirement |
| Metal Parts | All the metal parts should be properly grounded without any sharp Edges. | Safety Requirement |
| Leveling and Balancing | Equipment should be properly balanced & leveled. | Safety Requirement |
| Installation | All the Installation must be in accordance with the GMP. | Safety Requirement |
| Electrical Wiring And Earthing | Electrical wiring should be as per approved drawings. Double external Earthing to control machine (panel and motors) and operator should be provided. | Safety Requirement |
| Noise Level | Below 70 db. | Safety Requirement |
| Audio/Visual Alarm | Control system should take care for avoiding overshooting or under shooting of control parameter | Safety Requirement |
Spare parts / Change parts
Vendor should provide Preventive Maintenance SOP, List of recommended critical spare parts with code no. considering 2 years of satisfactory working of machine. After Sale Service/ AMC for the machine should be provided after warranty period. Vendor should provide all spares required for 2 years of use at the time of shipment.
List of Abbreviations.
| URS | User Requirement Specification |
| ENG | Engineering |
| QA | Quality Assurance |
| cGMP | Current Good manufacturing |
| mm | Milli Meter |
| Ltr | Litre |
| Hr | Hour |
| SS | Stainless steel |
| DQ | Drawing Qualification |
| FAT | Factory acceptance test |
| SAT | Site acceptance test |
| IQ | Installation Qualification |
| OQ | Operational Qualification |
| PQ | Performance Qualification |
| AMC | Annual maintenance Charge |
| HMI | Human machine interface |
| MCB | Miniature circuit breaker |
| DB | Decibel |
| VFD | Variable frequency drive |
| AC | Alternate Current |
| MOC | Material of Construction |
| PVC | Poly vinyl chloride |