COMPRESSED AIR SYSTEM

COMPRESSED AIR SYSTEM The main aim of the system is to produce and provide the desired quality compressed air as per the designed capacity at designed pressure. The Compressed Air System and quality of the compressed air distributed to all user points must comply with ISO8573, USP, BP and in-house requirements. The Quality refers to … Read more

Design of HVAC systems and components as per TRS 1010

Design of HVAC systems and components Proper design and management of HVAC systems is crucial throughout their entire life cycle. It is important to maintain documentation, such as schematic drawings, to accurately reflect the current state of the system. To ensure the safety and effectiveness of HVAC systems, risk management principles should be applied. This … Read more

Premises & HVAC system design

Premises & HVAC system design Both the architectural design of the building and the HVAC system design should be carefully considered to achieve the objectives of preventing contamination and cross-contamination and ensuring a suitable environment for pharmaceutical production and control. It is crucial to maintain the required environmental conditions, cleanliness, and containment. Infiltration of outside … Read more

Alarm management & Alarm Challenge Test

Alarm management Alarm management is the understanding, design, implementation, and use of effective alarm capabilities for plant operators. It is designed to notify the operator of situations or events that require the operator’s attention. Explicitly within a reasonable time frame. Designer of production process control systems. These systems are traditionally configured. Equipment for measuring the … Read more

QUALIFICATION PROTOCOL FOR AIR COMPRESSOR SYSTEM

QUALIFICATION PROTOCOL FOR AIR COMPRESSOR SYSTEM Air compressor system -The purpose of carrying out Qualification of Air compressor system is to establish the documented evidence that the system performance is in accordance with the predefined specifications. The scope of this protocol is to describe the procedure for different tests, acceptance criteria, Re-validation criteria and documentation to be … Read more

Orbital Welding

Orbital welding Orbital welding-The pipe or tube to be welded is held while the welding arc rotates (in “orbit”) around the workpiece. Welding parameters are set by a microprocessor, so settings can be saved and reused, ensuring a highly reproducible process. Orbital welding is the automatic or mechanized welding of pipes and tubes using an … Read more

Operational qualification protocol cum report

Operational qualification protocol cum report shall consist of minimum contents but not limited to. Overview Purpose Background Responsibility Requalification System Description HANDLING, MANAGEMENT, AND INVESTIGATION OF DEVIATION Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Deficiency (if any) and Corrective Action Report Acceptance criteria … Read more

Operation cum performance qualification protocol cum report

Operation cum performance qualification protocol cum report shall consist of minimum contents,but not limited to. TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description FBD Machine Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Performance Qualification Results Deficiency (if any) and Corrective Action … Read more

Performance qualification protocol cum report

Performance qualification protocol cum report shall consist of minimum contents but  not be limited to TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Performance Qualification Procedure Training Date Performance Qualification Results for Run-1 Performance Qualification Results for Run -2 Performance Qualification Results for Run-2 Deficiency (if any) and Corrective Action Report Acceptance criteria … Read more

Operation & time verification of digital clock

Operation & time verification of digital clock Digital Clock: A digital clock is a type of clock that displays the time digitally (i.e. in numerals or other symbols) as opposed to an analogue clock. Digital clocks are often associated with electronic drives but the “digital” description refers only to the display, not to the drive … Read more

The compressed air system in Pharma

The compressed air system in Pharma The Moisture free Compressed Air system comprises of state-of-the-art Vertical single cylinder reciprocating air-cooled compressor with a “V” Belt arrangement, starter cum control panel, safety devices, interconnecting piping, cabling, etc. and accessories duly mounted on a rigid steel deck. These packages are provided with anti-vibration mountings to reduce the … Read more

Accident Management

Accident Management To establish procedures to be followed at the time of any accident during production operation. RESPONSIBILITY: Department in charge –Implementation of SOP & Documentation. Production Supervisor  (Present at the time of the accident) – To take the necessary action as per SOP. S&E Person – Clearance from S&E aspects. ACCOUNTABILITY: Production HEAD PROCEDURE: Generally following types of … Read more

PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS

PROCEDURE FOR QUALIFICATION/ REQUALIFICATION OF SYSTEM/ EQUIPMENT/ UTILITY/ INSTRUMENTS PURPOSE To describe the procedure for preparation of qualification protocols, and reports and provide the guidelines for execution of qualification activity and related documentation. SCOPE This SOP shall be applicable for the qualification of all newly procured and upgraded systems/ equipment/utilities at Relax Pharmaceutical Pvt. Ltd … Read more

Temperature mapping protocol

Temperature mapping protocol A well-designed protocol will help ensure that the mapping study is correctly carried out. To cover the full range of temperature regimes, a standard protocol can be used to map any storage area in the facility The mapping protocol should contain the following sections: a. Approval page and change control history b. … Read more

Temperature Mapping report template

Temperature Mapping report template The mapping report should include the following sections: a. Introduction: a description of the objectives of the mapping study. b. Summary: a summary and discussion of the results organized in the sequence set out in the mapping protocol, including a summary of deviations (if any). c. Conclusions and recommendations: a general … Read more

Electronic data logging monitor (EDLM)

Electronic data logging monitor (EDLM): A small portable device that measures and stores temperature readings at predetermined time intervals by means of an electronic sensor. They have programmable alarm capabilities, and integrated displays, and can create reports and graphs which may be permanently stored, shared, and analyzed via proprietary hardware, software, desktop application, or hosted … Read more

HVAC SYSTEM AND TEST FOR HVAC QUALIFICATION

HVAC

HVAC SYSTEM AND TEST FOR HVAC QUALIFICATION What is HVAC? HVAC controls Temperature, Humidity, and Air quality inside a building. HVAC technology aims to provide thermal comfort and acceptable indoor air quality. HVAC system design is a sub-discipline of mechanical engineering, based on the principles of thermodynamics, fluid mechanics, and heat transfer. The HVAC system is … Read more

Air Handling Unit (AHU) and Working Principle

Air Handling Unit (AHU) and Working Principle An Air Handling Unit (AHU) is used to re-condition and circulate air as part of a heating, ventilating, and air-conditioning system. The basic function of the AHU is to take in outside air, re-condition it, and supply it as fresh air to a building. All exhaust air is … Read more

NITROGEN GAS DISTRIBUTION SYSTEM

nitrogen gas

NITROGEN GAS DISTRIBUTION SYSTEM WELDING AND CLEANING DETAILS CERTIFICATION Welder will be certified to a qualified welding procedure to be followed. Welder shall be certified in the use of the specific equipment and material being used in the welding process as per agreement with client. 10% of all orbital welded connections and 100% of all … Read more

PURIFIED WATER

purified water

PURIFIED WATER WELDING AND CLEANING DETAILS CERTIFICATION  Welder will be certified to a qualified welding procedure to be followed. Welder shall be certified in the use of the specific equipment and material being used in the welding process as per agreement with client. 10% of all orbital welded connections and 100% of all manually welded … Read more