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…
CLEANING AND OPERATION OF MULTI MILL Multi mill operates on the principle of variable force swing beaters having both knife and impact edges rotating within a selected screen to get the required size reduction. In multi mill particle size reduction is done through impact in air, on material by blades moving at high speeds, inside a cylindrical hopper.
CLEANING AND OPERATION OF OSCILLATING GRANULATOR OSCILLATING GRANULATOR is Solids size-reducer in which particles are broken by oscillating stirrer arranged over a screen of suitable mesh.
CLEANING AND OPERATION OF FLUID BED DRYER FLUID BED DRYER is used in the granulation process for drying the material to get desired moisture content. If the air is allowed to flow through a bed of solid powdered material in the upward direction with the velocity greater than the settling rate of the particles, the…
Warning Letter – October 20, 2023 The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, from February 20 to March 2, 2023. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210…
Clean Room Quiz 6 Question: What is the purpose of an airflow direction test and visualization? Answer: The purpose of an airflow direction test and visualization is to demonstrate that the airflow direction and its uniformity of velocity conform to the design and performance specifications. Question: What are the four methods used for performing the…
Clean Room Quiz 5 Question: What is recommended for measuring the supply air volume flow rate in cases where there is local airflow turbulence and jet velocities issuing from an outlet? Answer: It is recommended to use an airflow capture hood that captures all of the air issuing from each final filter or supply diffuser….
Clean Room Quiz 4 Question: What is the purpose of the airflow test? Answer: The purpose of the airflow test is to measure airflow velocity, uniformity, and supply air volume flow rate in cleanrooms and clean zones. This includes measuring velocity distribution in unidirectional airflow areas and supply air volume flow rate in non-unidirectional areas….
Clean Room Quiz 3 Question: When need to plan for testing and verification testing should be conducted according to the ISO 14644? Answer: Testing should be carried out at minimum during the following instances: a) In connection with classification according to ISO 14644-1; b) At verification during start-up; c) At verification after failures have been…
Clean Room Quiz 2 Question: What is the objective of the air pressure difference test.? Answer: The objective of the air pressure difference test is to confirm the effectiveness of the cleanroom’s air movement system in maintaining the designated pressure differential between the cleanroom and its surrounding environment. Question: When should the air pressure difference…
Clean Room Quiz 1 -Question & answers on Clean Room Question: What is the definition of an “airborne particle”? Answer: An airborne particle is described as a solid or liquid object suspended in the air, whether viable or non-viable, falling within a size range spanning from 1 nanometer (nm) to 100 micrometers (μm). Question: How…
SOP FOR HANDLING AND STORAGE OF DIES & PUNCHES
What is Pre-dispatch inspection? Pre-dispatch inspection is a step taken by manufacturers to inspect finished products before dispatch of the finished product for sale and distribution in the market for the supply of medicine to user points. The purpose of Pre-dispatch inspection is: Check the quantity and quality of the finished product. Check the product…
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…
Total Quality Management Practices Total Quality Management Practices (TQMS) the first thing that comes to mind when you think of the word “quality”? The word “quality” has many definitions. Quality can be defined as a characteristic or characteristic, as in the following statement: “They are honest people, and that is a good quality.” They also ask…
HANDLING AND INVESTIGATION OF INCIDENTS Incidents – Any unforeseen event or deviations from approved protocols or standard operating procedures without prior authorization and documentation. Any variance from established specifications or requirements stated in Quality System document, which includes but not limited to SOP (Standard Operating Procedure), BMR (Batch Manufacturing Record) and BPR (Batch Packing Record),…
QUALIFICATION STUDY FOR VISUAL INSPECTOR To establish documented evidence that Visual Qualification Protocol is capable to qualify the visual inspector, within the specified quality attributes thereby establishing the Visual Inspectors qualification procedure. Detect and remove units of drug product with predefined defects in a reproducible manner in a controlled process. Each final container of all…
ENVIRONMENTAL MONITOR To ensures clean and sterile conditions for compounding and preparing pharmaceutical products. Sterile compounding pharmacy environments and other cleanrooms can demonstrate compliance standards for monitoring and controlling airborne particles. ACPH. Manufacturing & storage rooms require at least 20 air changes per hour (ACPH) nonsterile area. Buffer rooms and interlock with access. Temperature. Cleanroom…
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…
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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…
