Pharma Editor

CHILLED WATER

CHILLED WATER Chilled water systems have become a pioneering solution, transforming how we cool our buildings and industrial areas. Going beyond conventional air conditioning techniques, It presents a sustainable and economical option. we delve into the fundamentals of chilled water technology, its wide-ranging applications, and the environmental and financial advantages …

Read More »

AIR COMPRESSORS

AIR COMPRESSOR OBJECTIVE: To lay down a procedure for the Maintenance of the Air compressor SCOPE: This SOP applies to Air compressors. RESPONSIBILITY: Technical Supervisor / Engineer        ACCOUNTABILITY: Sr.Executive / Manager                     PROCEDURE Daily Maintenance Check and ensure the oil level is as per the mark given on the view glass. …

Read More »

BOREWELL PUMP

BOREWELL PUMP Borewell pumps stand as silent workhorses, drawing water from the depths below. These essential devices have transformed the way we access and utilize groundwater, playing a pivotal role in sustaining life and supporting various economic activities. Borewell Pumps: Functionality: Borewell pumps are specialized devices designed to extract water …

Read More »

AIR HANDLING UNIT

Maintenance of Air Handling Unit OBJECTIVE: To lay down a procedure for the Maintenance of the Air Handling Unit SCOPE: This SOP applies to the Air Handling Unit. RESPONSIBILITY: Technical Supervisor / Engineer        ACCOUNTABILITY: Sr.Executive / Manager                     PROCEDURE :  Daily Maintenance Check and ensure that the difference between the inlet …

Read More »

CLEANING OF AIR HANDLING UNIT (AHU) FILTERS

OBJECTIVE To lay down a procedure for Cleaning of Air Handling Unit (AHU) filters  20 Micron, 10 Micron , 5 Micron  SCOPE This SOP is applicable to cleaning of Air Handling Unit (AHU) filters 20 Micron , 10 Micron, 5 Micron . RESPONSIBILITY  Technical Supervisor / Engineer ACCOUNTABILITY  Manager  PROCEDURE …

Read More »

Performance Qualification Protocol. Bung washer

OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the BUNG WASHING MACHINE. To verify the Rubber stopper washing process is capable of consistently and reliably removing Particulate matter contaminants, such as dust, lint, fibres etc., Bacterial Endotoxins, from the …

Read More »

Performance Qualification Protocol. Vial washing machine

OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the VERTICAL ROTARY VIAL WASHING MACHINE. To verify the vial washing process is capable of consistently and reliably producing appropriate washing of different types of vials at different speeds encountered in …

Read More »

Performance Qualification Protocol Vial sealing machine

Performance Qualification Protocol Vial sealing machine OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the Vial sealing Machine. To demonstrate that the equipment / system is performing reproducibly and consistently within its operating range of operation and suitable for …

Read More »

Performance Qualification Protocol for Vial Filling Machine

Performance Qualification Protocol for Vial Filling Machine OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the Vial Filling Machine. To Demonstrate that the equipment / system is performing reproducibly and consistently within its operating range of operation and fill …

Read More »

Sop for operation of BOPP taping machine

Objective: To lay down a procedure for operation of BOPP taping machine. Scope This SOP is applicable for operation of BOPP taping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Polypropylene IPQA : In-process Quality Assurance Procedure Pre-Start …

Read More »

SOP on operation of packing conveyer belt

Objective To lay down the procedure for the operation of packing conveyer belt. Scope:  The SOP is applicable for the operation of packing conveyer belt installed in the packing hall of sterile injectables facility.  Responsibility Officers and above-Production Accountability Production Head Abbreviations MCB : Miniature Circuit breaker Procedure Ensure that …

Read More »

SOP for operation of inkjet printing machine

Objective: To lay down a procedure for operation of Ink jet printing machine. Scope This SOP is applicable for operation of Ink jet printing machine (make:Image). Responsibility Officers or above – Production.  Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. LCD : Liquid Crystal Display Procedure Start-up Ensure the …

Read More »

SOP for operation of carton coding machine

Objective:To lay down a procedure for operation of carton coding machine. Scope: This SOP is applicable for operation of carton coding machine. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. No.: Number Date : Manufacturing Date Date : Expiry Date MRP : Maximum …

Read More »

SOP For Decartoning of primary and secondary packing materials.

Transfer the required quantity of seals from warehouse to decartoning room on the receipt of the packing material requisition slip. Decartoning of Seal Decartoning of Rubber Stopper Transfer the required quantity of stopper from warehouse to decartoning room on the receipt of the packing material requisition slip. The production officer …

Read More »

Performance Qualification Protocol. P.H.V. Steam Sterilizer

Performance Qualification Protocol. P.H.V. Steam Sterilizer OBJECTIVE The objective of this Validation Protocol is to obtain a high degree of assurance that the steam sterilization process is capable of sterilizing the specified loads using High Pressure and High Vacuum Steam Sterilizer (Bung Processor). To establish a documented evidence that the …

Read More »

Preparation of Validation and Qualification Protocols

Preparation of Validation and Qualification Protocols Objective To lay down a procedure for Preparation of Validation and Qualification protocols applicable to all aspects of manufacturing processes, equipments, control systems (including computer hardware and software), utilities, facility, temperature mapping, Shipping and any significant changes to the above mentioned elements which may …

Read More »

Operational qualification for pure steam generator

Operational qualification for pure steam generator OBJECTIVE 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) …

Read More »

Template for Performance Qualification Protocol

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 …

Read More »

Template for Mapping of the Environmental condition

Template for 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 …

Read More »

Template Protocol for 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., …

Read More »