Tiêu đề URS Walk In Type Stability Chamber.pdf ✅

Company Name Equipment Name Walk In Type Stability Chamber Page 1 of 6 Document No. URS/TH/WS/001 E-mail: [email protected] Web site: www.pharmaceuticalsky.com USER REQUIREMENT SPECIFICATION OF WALK IN TYPE STABILITY CHAMBER
Company Name Equipment Name Walk In Type Stability Chamber Page 2 of 6 Document No. URS/TH/WS/001 E-mail: [email protected] Web site: www.pharmaceuticalsky.com INDEX 1.0 OBJECTIVE: ____________________________________________________________________ 3 2.0 SCOPE: _________________________________________________________________________ 3 2.1 BASIC OF SYSTEM:___________________________________________________________________ 3 3.0 ACCURACY AND UNIFORMITY:___________________________________________________ 3 4.0 STAND BY SYSTEMS: ____________________________________________________________ 3 5.0 CONTROL SYSTEM:______________________________________________________________ 4 5.1 PLC WITH TOUCH SCREEN: __________________________________________________________ 4 5.2 DOOR ACCESS SYSTEM:______________________________________________________________ 4 5.3 MOBILE ALERT SYSTEM: ____________________________________________________________ 4 5.4 CONTROL PANEL: ___________________________________________________________________ 5 6.0 SAFETY FEATURES:_____________________________________________________________ 5 6.1 SAFETY LIMIT CUT OFF FOR LOW / HIGH TEMPERATURE HIGH HUMIDITY: ___________ 5 6.2 SAFETY THERMOSTAT: ______________________________________________________________ 5 6.3 HUMIDITY SAFETY THERMOSTAT: ___________________________________________________ 5 6.4 WATER LEVEL SAFETY: _____________________________________________________________ 5 6.5 COMPRESSOR SAFETY: ______________________________________________________________ 5 6.6 ELECTRICAL SAFETY: _______________________________________________________________ 5 7.0 OPTIONAL ACCESSORIES: _______________________________________________________ 5 7.1 SOFTWARE: _________________________________________________________________________ 5 7.2 HARDWARE CARD FOR SOFTWARE __________________________________________________ 5 7.3 PRINTER:____________________________________________________________________________ 5 7.4 WATER TANK: _______________________________________________________________________ 5 8.0 VALIDATION DOCUMENTATION:_________________________________________________ 6 9.0 CUSTOMER APPROVAL: _________________________________________________________ 6
Company Name Equipment Name Walk In Type Stability Chamber Page 3 of 6 Document No. URS/TH/WS/001 E-mail: [email protected] Web site: www.pharmaceuticalsky.com 1.0 OBJECTIVE: This document is to identify the User requirements of the Walk in Type Stability Chamber. This is a basic document for the Stability system and it will be used for further life cycle of project. The requirements specified in this document will be verified in Performance Qualification tests. The User Requirement for Procurement of Walk in Type Stability Chamber capable of maintaining desired temperature and humidity and accommodating required number of samples with a capacity of approximately ➢ 15000 Ltrs :  2.0 SCOPE: The scope of this document is applicable to the Walk in Type Stability Chamber with the following conditions: 25°C & 60% RH Condition 30°C & 65% RH Condition 40°C & 75% RH Condition 2.1 BASIC OF SYSTEM: • Capacity : 15000 Ltrs • Inner Size (W X D X H) : 2,500 W x 3,000 D x 2,000 H mm • Material of Construction Model: SG15K0B804 : Inside S.S.304 Outside S.S.304 • Total No. of Racks : 2 Nos. • Total No. of Trays : 30 Nos. • Environment condition temperature and humidity specified requirement as per ICH guideline Running condition : Temperature ____°C & Humidity ____% RH 3.0 ACCURACY AND UNIFORMITY: Accuracy : Temperature + /- 0.2°C & Humidity + /- 2% RH Uniformity : Temperature + /- 2.0°C & Humidity + /- 3% RH 4.0 STAND BY SYSTEMS: a) Humidity A standby humidity system, which should work in case of failure of the regular humidity system b) Refrigeration A standby refrigeration system, which should work in case of failure of the regular refrigeration system   