Tag: Cumbria

Steam Sterilizer H.P.H.V. Steam sterilizer is installed in vial washing room. Purpose Of The Equipment Purpose of this H.P.H.V. Steam sterilizer is for sterilization and drying of the garments, rubber stopper holding canisters, filling machine parts, filtration accessories and previously washed and siliconized rubber stoppers. Basic Mode Of Operation The main action of H.P.H.V. Steam…

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Operational qualification for pure steam generator To establish documentary evidence to demonstrate the Pure Steam Generator  system is qualified for correct operation as per guidelines outlined in this protocol & operational manual. SCOPE OF THIS DOCUMENT This protocol is applicable to pure steam generator. Functional testing (including safety tests) of the equipment with printouts for…

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Performance Qualification Protocol OBJECTIVE To describe the Performance Qualification procedure to be used during qualification of NAME OF THE EQUIPMENT system in order to: Ensure the system reproducible over an appropriate time period as per user requirement specifications Ensure that the system is showing consistency in producing Product of pre-established specifications. SCOPE This procedure applies…

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Mapping of the Environmental condition Objective The objective of this validation study is to provide a document evidence of Temperature and Relative Humidity distribution in Ware House area against predetermined acceptance criteria. Scope The validation study of the Temperature and Relative Humidity distribution in Ware House area shall be carried out for one year on…

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Shipping validation Objective The objective of this study is to establish a procedure to records temperature data to ensure that transportation conditions have not adversely affected a products, when transported as per regular Shipment practice. Scope The Shipping (Transportation) validation study shall be carried out for four times covering four seasons viz., Winter, Spring, Summer…

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Operational Qualification Report PURPOSE To describe the Operational Qualification of Name of the Equipment and to define the specification of the system in order to: Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices Ensure that the equipment meets the Operational/Design limits as per user requirements. SCOPE The scope…

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Operational Qualification Protocol PURPOSE To describe the Operational Qualification of Name of the Equipment and to define the specification of the system in order to: Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices Ensure that the equipment meets the Operational/Design limits as per user requirements. SCOPE The scope…

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WFI generation, storage and distribution system Brief Instrument Description: The Water For Injection System Still is working on the Principle of inters stage heat exchange (Reuse of energy) drastically reduce the consumption of heat energy and cooling water. Thus enable to produce large- scale of Pyrogen free sterile water for injection. The Distillation Column operates…

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Template for Installation Qualification Protocol PURPOSE To describe the Installation Qualification procedure to be used during qualification of Name of Equipment machine to define the Specification of the system in order to Ensure that the equipment meets the specification as per Design Qualification (Doc Number). Aid verification of the installation as per equipment general arrangement…

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Template for User Requirement Specification TECHNICAL SPECIFICATION General Equipment No. Description Use Field Identification Glossary Salient Features General Material of Construction Finish  – Smooth  Finish/matt finish/mirror finish Electrical Construction – Non flameproof / flameproof Operational requirements Capacity Control Parameter Desired Accuracy Control Data & Security User interface with supervisors and operators for the control platform Interface…

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Template for Process validation protocol To provide documented evidence with a high degree of assurance that the manufacturing process is capable of producing the finished product consistently of the required quality, meeting its predetermined specifications and quality attributes. Scope: This process validation protocol is applicable to carry out process validation of the Name of the…

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Installation qualification for pure steam generator To confirm, by physical inspection and testing, that the fabrication and assembly of the equipment and any auxiliary support systems, conform to the Design parameters as per the Design Review. SCOPE  The tests shall be carried out at the customer’s place. The verification of compliance to specifications as per…

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