sop-of-Revalidation/Requalification of HVAC system

 sop-of-Revalidation/Requalification of HVAC system objective Scope Responsibility Qualification team Abbreviation and definition Pre-requisites Precautions and instruction (Health, Safety, and Environment) Air velocity, the Air volume, and air Change Per hour measurement Procedure for HEPA Filter integrity Procedure for non-viable particle count Procedure for viable particle count Recovery Study Airflow Visualization Procedure for Temperature, Relative Humidity, … Read more

REQUIREMENTS OF PHARMACEUTICAL MANUFACTURING PLANT AND EQUIPMENT

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BASIC REQUIREMENTS OF PHARMACEUTICAL MANUFACTURING PLANT AND EQUIPMENT 1. External Preparations. – The following equipment’s are recommended for the manufacture of External preparations i.e. Ointments, Emulsion, Lotions, Solutions, Pastes, Creams, Dusting powders and such identical products used for external applications whichever is applicable, namely :- (1) Mixing and storage tanks preferably of stainless steel or … Read more

WATER SYSTEM

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 WATER SYSTEM: A purified Water system is a basic requirement for Pharmaceutical Industries. Raw Water sourced from industry bore well water is converted into purified water complying with current USP/ BP/ IP/ Ph. Eur. GENERATION OF PURIFIED WATER: The raw water passes through a sand filter through a transfer pump. This will remove solid particles … Read more

HEATING, VENTILATION AND AIR CONDITIONING (HVAC) SYSTEMS

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BRIEF DESCRIPTION OF HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SYSTEMS: To avoid cross-contamination and to maintain relative humidity, temperature, and Pressure Difference of the manufacturing areas with Air handling Units, ­­­­­Air handling Units Provided in the manufacturing, warehouse, quality control, and microbiology section. Temperature and humidity are controlled and maintained within the limits as per … Read more

Equipment Qualification

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Equipment Qualification Manufacturers must establish a systematic approach to qualification and validation to guarantee the quality, safety, and effectiveness of their products throughout their lifecycle. It is crucial to employ statistical evaluation when necessary to provide scientific evidence that the processes, systems, or other relevant aspects are appropriately qualified or validated. The qualification and validation … Read more

GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS

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GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS I. SYSTEM DESIGN For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used, This applies to the formulation of products, as well as to the final washing of components and equipment used in their manufacture. Distillation and … Read more

Engineering Documentation in Pharmaceutical Industry

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Engineering Documentation in Pharmaceutical Industry Heat Load Calculations. AHU Zoning drawing with pressure differentials. Airflow diagram. Ducting layout. Piping Layout. Hepa Box G.A. Man Movements layout Material Movements layout The layout of Pressure difference and area classification in production Area Qualification Area Mapping Commissioning Report of HVAC System Airflow & ACPH (Room wise) Filter Integrity … Read more

Environmental Monitoring

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Environmental Monitoring – All environmental parameters listed under para 3.1 to 3.10 shall be verified and established at the time of installation and thereafter monitored at periodic intervals. The recommended frequencies of periodic monitoring shall be as follows: ( a ) Particulate monitoring in air – 6 Monthly (b) HEPA filter integrity testing (smoke testing) … Read more

List OF SOPs ENGINEERING

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List OF SOPs ENGINEERING S. No. SOP Title 1. Preventive Maintenance 2. Breakdown Maintenance Procedure of the Equipment and Machines 3. Colour Coding of Utility Lines 4. Procedure for Building Maintenance 5. Calibration of Equipment and Instrument from External Authorized Body / Suppliers 6. Operating procedure of Vacuum Circuit Breakers and Transformers 7. Changeover from … Read more

Principles of HVAC Duct Design in Pharma Industry

Principles of HVAC Duct Design in the Pharma Industry How Does a Duct System Work  The duct, or air distribution, system used in cooling and heating your area is a collection of tubes that distributes the heated or cooled air to the different rooms in the Pharma Industry. This branching network of round or rectangular … Read more

PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT

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PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT OBJECTIVE; To define the procedure for preventive maintenance of production equipment. SCOPE: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: Mechanical Engineer ACCOUNTABILITY: Engineer Head ATTACHMENTS: Attachment I – Preventive maintenance schedule Attachment IІ – Preventive … Read more

All Post URL of Drugs formulations

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All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride Tablet (drugsformulations.com) Norethisterone Tablet (drugsformulations.com) Metformin … Read more

DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM

DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM TABLE OF CONTENTS DESIGN QUALIFICATION PROTOCOL APPROVAL INTRODUCTION OBJECTIVE: SCOPE RESPONSIBILITY BASIS OF DESIGN SYSTEM DESCRIPTION SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS PANEL INTERLOCKS AND OPERATIONAL LOGICS CRITICAL SAFETY REQUIREMENTS SAMPLING PLAN SANITISATION CYCLE LIST OF APPROVED MAKES DESIGN QUALIFICATION APPROVAL INTRODUCTION United State Pharmacopoeia (USP) … Read more

Effluent Treatment Plant (ETP)

Effluent Treatment Plant (ETP) Effluent Treatment Plants (ETP) play a vital role in this endeavor, serving as essential systems for the treatment and purification of industrial wastewater. This article explores the importance, operation, and environmental implications associated with Effluent Treatment Plants. Effluent Treatment Plants are crucial for the responsible and sustainable management of industrial wastewater. … Read more

Sanitization & Cleaning SOP ( RO )

Chemical Sanitization Procedure for RO first Pass Objective : To Disinfectant the Bacteria in RO membrane Scope :- Procedure : Prepare (0.1 – 1) % Minncare Solution in any solution preparation tank having the capacity of 300 Ltr      { Use  300ml of 100% Minncare in 300 Ltrs of Purified Water at Ambient Temp} Connect … Read more

Dust control during AHU design in Pharma Company

Dust control during AHU design in Pharma Company Dust control in Pharma Company in measure challenge Wherever possible, dust or vapour contamination should be removed at source. Point-of-use extraction, i.e. as close as possible to the point where the dust is generated, should be employed. Spot ventilation or capture hoods may be used as appropriate. Point-of-use … Read more

VALIDATION OF HVAC SYSTEM

VALIDATION OF HVAC SYSTEM INSTALLATION   QUALIFICATION PROTOCOL FOR AIR HANDLING UNIT & AIR DISTRIBUTION SYSTEM TABLE OF CONTENTS Sr. No Description Page No. 1 Objective 2 System / Equipment Description 3 Responsibility 4 Execution Team 5 Installation Verification 6 Installation Check 7 Documentation Requirement 8 Deviation Report 9 Installation Qualification Summary & Conclusion 10 Abbreviations 11 … Read more

MAINTENANCE OF VENTILATION SYSTEMS (EXHAUST)

OBJECTIVE            To lay down a procedure for Maintenance of Ventilation System SCOPE This SOP is applicable to Ventilation System (Exhaust).  RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Weekly Maintenance Check condition of the belt for wear, tear and damage and replace if damaged and  clean the area with cora cloth  Ensure no air … Read more

MAINTENANCE OF VENTILATION SYSTEMS (SUPPLY)

OBJECTIVE            To lay down a procedure for Maintenance of Ventilation System SCOPE  This SOP is applicable to Ventilation System (Supply). block. RESPONSIBILITY Technical Supervisor / Engineer        ACCOUNTABILITY Sr.Executive / Manager                     PROCEDURE Weekly Maintenance Check condition of the belt for wear, tear and damage and replace if  damaged and  clean the area with cora cloth Ensure no … Read more

CLEANING OF WATER OVER HEAD TANKS & SUMPS

CLEANING OF WATER OVER HEAD TANKS & SUMPS OBJECTIVE                                               To lay down a procedure for Cleaning of Water Over Head Tanks and Sumps SCOPE  This SOP is applicable to Water Over Head Tanks and Sumps. RESPONSIBILITY             Technical Supervisor / Engineer ACCOUNTABILITY                     Sr.Executive / Manager PROCEDURE Obtain work permit for carrying out cleaning. Ensure that all … Read more