Production Department in Pharmaceutical Industry
Production Department-The process of Drug Manufacturing performed in Production Department in Pharmaceutical Unit into a series of unit operations, such as dispensing, granulation, coating, tablet pressing, blistering, mixing, filling, and others.
Table of Contents
Air Flow Pattern Under LFA in
Aseptic Processing SOP: This SOP outlines the specific air flow patterns required for maintaining cleanliness and sterility in aseptic processing areas, particularly under Laminar Flow Hoods (LFA). It likely details the direction and velocity of airflow to prevent contamination of sensitive products or materials.Pharmaceutical Engineering
Terminal Sterilized
Process Area Grading & its Cleaning: This SOP establishes the criteria and procedures for grading and cleaning aseptic and terminal sterilized process areas. It likely includes guidelines for assessing cleanliness levels, defining cleaning protocols, and maintaining sterile conditions to ensure product safety.
Assigning Mfg, Exp Dates to Batches SOP: This SOP defines the process for assigning manufacturing and
expiration dates to batches of pharmaceutical products. It likely involves considerations such as production dates, shelf life, stability testing results, and regulatory requirements.
Assigning Work to Various
Workers on Packing Line SOP: This SOP outlines the procedure for assigning tasks and responsibilities to workers on a pharmaceutical packaging line. It may include guidelines for task rotation, training requirements, and ensuring adherence to quality standards during packaging operations.
Batch Stamp Preparation SOP:
This SOP describes the process for preparing batch stamps, which are used to label and identify individual batches of pharmaceutical products. It may cover aspects such as stamp design, ink selection, and proper application techniques to ensure accurate batch identification.
Cleaning Mopping & Fumigation of Aseptic Area SOP: This SOP provides instructions for cleaning, mopping, and fumigating aseptic processing areas to maintain cleanliness and sterility. It likely includes details on cleaning agents, equipment, frequency of cleaning, and safety precautions to prevent contamination.
Cleaning of Compounding Tanks (Sterile Area): This SOP outlines the procedures for cleaning compounding tanks in sterile areas of pharmaceutical manufacturing facilities. It may include disassembly instructions, cleaning agents, sanitization methods, and validation requirements to ensure microbial control.
Cleaning of Equipment & Accessories SOP: This SOP details the cleaning procedures for pharmaceutical manufacturing equipment and accessories to prevent cross-contamination and ensure product quality. It may include disassembly, cleaning agents, sanitization methods, and inspection criteria.
Destruction of Expired, Rejected Materials SOP: This SOP defines the process for the safe and proper destruction of expired or rejected materials in pharmaceutical manufacturing. It likely includes guidelines for segregation, disposal methods, documentation, and regulatory compliance.
Drain Cleaning In Production Area SOP: This SOP outlines the procedures for cleaning drains in production areas to prevent microbial growth and contamination of pharmaceutical products. It may include scheduling, cleaning agents, equipment, and safety precautions.
Entrance in Sterile Area: This SOP outlines the protocol for personnel entering sterile areas within the pharmaceutical manufacturing facility. It likely includes procedures for gowning, hand hygiene, and any other measures necessary to maintain the sterility of the environment and products.
Entrance of Worker into Injectable Area: This SOP specifically details the procedures for workers entering areas where injectable pharmaceutical products are handled or processed. It may include additional precautions and requirements due to the heightened sensitivity and sterility requirements of injectable products.
Entry To Aseptic Area SOP: Similar to the previous SOPs, this one focuses on the procedures for entering aseptic areas within the facility. It may include specific requirements for gowning, personnel flow, and contamination control to ensure the integrity of aseptically processed products.
Entry/Exit Procedure to Production Area SOP: This SOP establishes the entry and exit procedures for personnel accessing general production areas within the facility. It may include requirements for hygiene practices, access control, and safety protocols to maintain a controlled environment.
Filling Of BMR Documents SOP: This SOP outlines the process for completing and filing Batch Manufacturing Records (BMRs) during pharmaceutical production. It likely includes instructions for documenting manufacturing steps, recording critical data, and maintaining compliance with regulatory
requirements.
Fumigation of Production Area: This SOP details the procedures for fumigating production areas to control microbial contamination. It may include protocols for selecting fumigants, application methods, safety precautions, and post-fumigation procedures to ensure worker safety and product integrity.
Good Practices in Sterile Area: This SOP provides guidelines and best practices for maintaining cleanliness, hygiene, and sterility in sterile areas of the facility. It may cover a range of topics such as gowning procedures, cleanroom behavior, and contamination prevention measures to uphold product
quality standards.
Gowning and Degowning Sterile Area Objective: This SOP outlines the proper procedures for donning (gowning) and removing (degowning) sterile attire when entering or exiting sterile areas. It may include step-by-step instructions, hygiene requirements, and equipment inspection criteria to prevent contamination.
Handling of Controlled Items in Production Area SOP: This SOP specifies the procedures for handling controlled substances or items within production areas. It may include inventory management, storage requirements, access control measures, and documentation practices to ensure regulatory compliance
and prevent misuse.
Identification & Traceability SOP: This SOP establishes protocols for identifying and tracing materials, products, and batches throughout the production process. It may include labeling requirements, barcode systems, and documentation practices to ensure accurate tracking and accountability.
In-Process Material Handling SOP: This SOP outlines the procedures for handling and transporting materials within the production area during various stages of the manufacturing process. It may include guidelines for material flow, equipment usage, and safety precautions to prevent contamination or damage.
Issuance And Coding Of Packaging Components SOP: This SOP details the process for issuing and coding packaging components used in pharmaceutical packaging. It may include inventory management, labeling requirements, and documentation practices to ensure traceability and compliance with regulatory
standards.
Loading of Ampoules and Vials In Hot Air Oven For Sterilization: This SOP provides instructions for loading ampoules and vials into hot air ovens for sterilization purposes. It may include loading patterns, temperature settings, and validation procedures to ensure effective sterilization of the containers.
Maintaining machine usage log SOP: This SOP establishes guidelines for maintaining a log of machine usage in the production area. It may include recording parameters such as machine start and stop times, maintenance activities, and any deviations from standard operating procedures to ensure equipment reliability and product quality.
Manual Optical Checking Lamp in Pharmaceuticals: This SOP describes the procedures for manually inspecting pharmaceutical products using an optical checking lamp. It may include inspection criteria, lighting conditions, and documentation practices to detect defects and ensure product quality.
Measuring of Temperature And Relative Humidity SOP: This SOP outlines the procedures for measuring temperature and relative humidity in critical areas of the facility. It may include calibration requirements, sensor placement, and data recording practices to ensure environmental control and compliance with regulatory standards.
Method Of Entry For Materials Which Cannot Be Sterilized By Steam: This SOP provides guidelines for introducing materials into sterile areas that cannot undergo steam sterilization. It may include alternative sterilization methods, such as chemical sterilization or irradiation, and validation procedures to ensure sterility assurance.
Packing of a product on a packaging line SOP: This SOP details the procedures for packing pharmaceutical products on a packaging line. It may include packaging material preparation, equipment setup, line clearance, and quality checks to ensure accurate and efficient packaging operations.
Packing of Tablets & Capsules in packaging section SOP: This SOP specifically focuses on the packing procedures for tablets and capsules in the packaging section of the facility. It may include packaging material handling, labeling requirements, and documentation practices to ensure product integrity
and compliance with regulatory standards.
Preparation Of Area Before Long Shut Down SOP: This SOP outlines the procedures for preparing production areas before an extended shutdown period. It may include equipment cleaning, inventory management, and safety checks to ensure readiness for resuming operations after the shutdown.
Preparation Of Disinfectant Solution SOP: This SOP provides instructions for preparing disinfectant solutions used for cleaning and sanitizing purposes in the production area. It may include dilution ratios,
mixing procedures, and storage requirements to ensure effective microbial control.
Product Change Over Procedure SOP: This SOP describes the procedures for changing over production equipment and processes to switch between different products. It may include cleaning protocols, equipment adjustments, and validation procedures to prevent cross-contamination and ensure product
quality.
Receiving batches for packaging from production department: This SOP outlines the procedures for receiving batches of finished products from the production department for packaging. It may include inspection, documentation, and quarantine practices to ensure product traceability and compliance with
quality standards.
Retaining of sample of Finished Goods SOP: This SOP establishes guidelines for retaining samples of finished goods for quality control purposes. It may include sampling procedures, storage conditions, and
documentation practices to ensure representative samples are available for testing and analysis.
Returned Goods Handling SOP: This SOP provides instructions for handling returned goods or products that do not meet quality standards. It may include inspection, disposition, and documentation procedures to address customer complaints and ensure proper handling of returned items.
Emulsifier SOP: This SOP outlines the procedures for using emulsifiers in pharmaceutical formulations. It may include formulation guidelines, mixing procedures, and quality control checks to ensure proper emulsion stability and product efficacy.
Sterile Area Classification: This SOP defines the classification criteria for sterile areas within the facility based on cleanliness levels and contamination risks. It may include cleanroom designations, monitoring
requirements, and access controls to maintain sterile conditions and product integrity.
Sterilization of Personnel Grab: This SOP describes the procedures for sterilizing personnel grabs or tools used in sterile areas. It may include sterilization methods, validation procedures, and frequency requirements to prevent microbial contamination and ensure worker safety.
Storage And Handling Of Finished Product SOP: This SOP provides guidelines for storing and handling finished products in the warehouse or storage areas. It may include inventory management, storage conditions, and rotation practices to prevent product deterioration and ensure compliance with regulatory standards.
Storage And Handling Of In-process Product SOP: This SOP outlines the procedures for storing and handling in-process products during various stages of the manufacturing process. It may include segregation requirements, environmental controls, and documentation practices to prevent mix-ups and
ensure product traceability.
Transfer Of Material Through Hatch SOP: This SOP describes the procedures for transferring materials through hatches or pass-throughs between different areas of the facility. It may include material handling protocols, inspection requirements, and documentation practices to prevent contamination and ensure traceability.
Transfer Raw Material in Sterile Area: This SOP provides instructions for transferring raw materials into sterile areas of the facility. It may include material staging, sterilization requirements, and transfer procedures to prevent microbial contamination and maintain product integrity.
Trials For New Products SOP: This SOP outlines the procedures for conducting trials or pilot runs for new pharmaceutical products. It may include formulation adjustments, process validation, and documentation practices to evaluate product performance and ensure readiness for full-scale production.
Unloading Of Ampoules, Vials From Hot Air Oven: This SOP details the procedures for unloading ampoules and vials from hot air ovens after sterilization. It may include cooling protocols, handling precautions, and inspection procedures to prevent product damage and ensure sterility.
Verification of Weighing Balance SOP: This SOP describes the procedures for verifying the accuracy and calibration of weighing balances used in pharmaceutical manufacturing. It may include calibration checks, weight verification, and documentation practices to ensure reliable measurements and compliance with quality standards.
Washing / Sterilization Of Seals, Uniforms & Surgical Gloves: This SOP provides instructions for washing and sterilizing seals, uniforms, and surgical gloves used in sterile areas. It may include cleaning methods,
sterilization cycles, and validation procedures to prevent microbial contamination and ensure worker safety.
Water Treatment Plant SOP: This SOP outlines the procedures for operating and maintaining the water treatment plant within the facility. It may include water purification processes, quality control checks, and maintenance activities to ensure the production of high-quality water for pharmaceutical manufacturing processes.
Production Machineries Production Department
Tablet
Operation of U-type Mixer: A U-type mixer is a type of mixing equipment used in various industries to blend dry or wet materials. The operation involves loading the materials into the mixing chamber, where they are agitated and mixed by rotating blades or paddles mounted on a horizontal shaft. The U-shaped design of the mixer provides efficient mixing by continuously lifting and tumbling the materials.
Operation of Rotary Wet Granulator: A rotary wet granulator is used in pharmaceutical manufacturing to form wet granules from powders by mixing them with a liquid binder. The operation involves feeding the powders and binder into the granulator, where they are mixed and kneaded by rotating blades or impellers. The resulting wet granules are then dried or further processed.
Operation of Powder Tray Dryer: A powder tray dryer is used to dry wet granules or powders in pharmaceutical, chemical, or food processing industries. The operation involves spreading the wet material onto trays and placing them inside the dryer chamber. Hot air is circulated through the chamber to evaporate moisture from the material, resulting in dried product.
Operation of Oscillating Granulator: An oscillating granulator is used to break down granules produced by wet granulation into smaller particles or to size-reduce dry granules. The operation involves feeding the granules into the granulator, where they are crushed and granulated by a rotor with oscillating blades. The granules are then discharged through a screen of desired size.
Operation of Double Cone Mixer: The operation of a double cone mixer involves blending dry powders or granules to achieve uniformity. The mixer consists of two conical-shaped vessels connected at the apex, rotating on a common shaft. During operation, the materials to be mixed are loaded into the mixer, and the rotation of the cones causes the contents to tumble and mix thoroughly.
Operation of Compressing Machine: A compressing machine, also known as a tablet press, is used in pharmaceutical manufacturing to compress granules or powders into tablets of uniform size, shape, and weight. The operation involves feeding the granules into the machine’s hopper, which then passes them
through a die cavity where compression occurs under high pressure, forming tablets.
Operation of Coating Machine: A coating machine is used to apply a coating, such as a polymer or sugar film, onto tablets, pellets, or granules to improve taste, appearance, or stability. The operation involves
loading the material into a rotating drum or pan, spraying the coating solution onto the surface of the particles, and drying the coated product to form a uniform coating layer.
Operation High Efficiency Intelligent Coating Machine: This appears to be a specific type of coating machine with advanced features for efficiency and automation. The operation would involve similar steps as a standard coating machine, but with added automation and control features for improved performance.
Operation of Blister Packing Machine: A blister packing machine is used to package solid dosage forms, such as tablets or capsules, into individual blister packs. The operation involves feeding blister packaging material and product into the machine, forming cavities in the material, filling each cavity with the product, sealing the cavities with a backing material, and cutting the packs into individual units.
Operation of Conveyor Belt: This SOP outlines the procedures for safely operating a conveyor belt system used for transporting materials or products within a manufacturing or processing facility. It includes instructions for starting and stopping the conveyor, loading and unloading items, adjusting conveyor speed and direction, inspecting the belt for damage or debris, and maintaining proper alignment and tension.
Operation of Fluid Bed Dryer: A fluid bed dryer is used to dry granules or powder by suspending them in a stream of hot air or gas. The operation involves feeding the wet material into the fluidized bed chamber,
where it is fluidized and dried by the heated air. The dried product is then discharged from the dryer.
Operation of Ribbon Blade Mixer: A ribbon blade mixer is used for blending dry powders, granules, or other materials in various industries. The operation involves loading the materials into the mixer’s trough, where a set of helical ribbon blades rotates and mixes the contents thoroughly. The ribbon design ensures efficient blending and uniform distribution of ingredients.
SOP of Tablet Deduster: An SOP for a tablet deduster outlines the procedures for safely and effectively operating a machine used to remove excess powder or debris from the surface of tablets after compression. The SOP includes steps for setting up the deduster, loading tablets, adjusting parameters for optimal dedusting, monitoring the dedusting process, and performing routine maintenance.
Blister Packing Machine (Alu-Alu): A blister packing machine (Alu-Alu) is specifically designed for packaging pharmaceutical products in blister packs with aluminum-aluminum (Alu-Alu) foil. The operation involves feeding the blister cavities with product, sealing them with Alu-Alu foil, and punching out individual blister packs. This type of packaging provides excellent barrier properties and protection against moisture, light, and oxygen.
Capsule Production Department
Operation of Double Cone Mixer: The operation of a double cone mixer involves blending dry powders or granules to achieve uniformity. The mixer consists of two conical-shaped vessels connected at the apex, rotating on a common shaft. During operation, the materials to be mixed are loaded into the mixer, and the rotation of the cones causes the contents to tumble and mix thoroughly.
Operation of Capsule Polisher: A capsule polisher is used to remove excess powder or fine particles from the surface of filled capsules, ensuring a clean and polished appearance. The operation involves feeding capsules into the polishing chamber, where they undergo agitation and rotation against polishing pads or brushes, effectively removing any loose powder or debris.
Operation of Material Transfer Hatch: A material transfer hatch is a specialized access point in a controlled environment, such as a cleanroom or sterile area, used for transferring materials between different areas while maintaining environmental integrity. The operation typically involves opening and closing the hatch in a controlled manner, ensuring proper sealing to prevent contamination.
Manual Capsule Filling Machine: A manual capsule filling machine is a device used to fill empty capsules with powdered or granular materials manually. Operators load empty capsules into the machine, fill them with the desired material using a manual filling tray or tool, and then close the capsules manually using a tamper or capsule closing mechanism.
Semi-Automatic Capsule Filling Machine: A semi-automatic capsule filling machine automates some of the processes involved in capsule filling, such as capsule loading and material filling, but still requires manual intervention for capsule separation, closing, and ejection. Operators load empty capsules and fill them with material using the machine, but may need to manually separate filled capsules and perform final closing steps.
Automatic Capsule Filling Machine: An automatic capsule filling machine is a fully automated device that handles all aspects of capsule filling, including capsule loading, material filling, separation, closing, and ejection. The operation involves minimal manual intervention, with the machine performing most tasks automatically to increase efficiency and productivity.
Operation of Laminar Air Flow Hood: A laminar air flow hood is a type of clean bench used to create a sterile work environment for handling sensitive materials or processes. The operation involves creating a laminar airflow within the hood, which directs clean, filtered air over the work surface, minimizing the risk of contamination. Operators work within the hood to perform tasks such as sample preparation, assembly, or packaging under sterile conditions.
Operation of Conveyor Belt: The operation of a conveyor belt involves transporting materials or products from one location to another within a facility. The conveyor belt consists of a continuous loop of belt material supported by rollers or pulleys. During operation, materials are loaded onto the belt at one end and conveyed along the length of the belt to the desired destination.
Operation of Blister Packing Machine: A blister packing machine is used to package solid dosage forms, such as tablets or capsules, into individual blister packs. The operation involves feeding blister packaging material and product into the machine, forming cavities in the material, filling each cavity with the product, sealing the cavities with a backing material, and cutting the packs into individual units.
High Speed Mixer: A high-speed mixer is a type of mixing equipment designed to blend materials quickly and efficiently. It typically features a rotating mixing blade or impeller that generates high shear forces to achieve rapid mixing. High-speed mixers are used in various industries, including pharmaceuticals, chemicals, and food processing, for applications requiring fast and thorough blending of ingredients.
Oral Liquid (Syrup, Suspension, Solution & Drop)
Automatic Syrup Filling Machine: An automatic syrup filling machine is a piece of equipment used in the
pharmaceutical or food industries to accurately fill containers, such as bottles or vials, with syrup or other liquid products. It typically consists of a conveyor belt to transport containers, a filling mechanism to dispense the syrup, and controls to regulate filling volume and speed automatically.
Mixing Tank: A mixing tank is a vessel used in various industries, including pharmaceuticals, food processing, and chemicals, for blending and homogenizing liquids or powders. It typically features an agitator or mixer to facilitate thorough mixing and may include temperature control and monitoring systems to maintain process conditions.
Storage Tank: A storage tank is a container used to store liquids or gases for short-term or long-term storage. In industrial settings, storage tanks are commonly used to hold raw materials, intermediate products, or finished goods before further processing, packaging, or distribution.
Bottle Blowing Machine: A bottle blowing machine, also known as a blow molding machine, is used in the manufacturing of plastic bottles. It works by heating plastic resin and then blowing compressed air into a mold to create the desired bottle shape. These machines are commonly used in the beverage, pharmaceutical, and household product industries.
Colloidal Mill: A colloidal mill is a type of rotor-stator mixer used for the reduction of particle size in suspensions or emulsions. It operates by subjecting materials to intense mechanical forces, resulting in the breakdown of particles to produce colloidal suspensions or finely dispersed emulsions. Colloidal mills are commonly used in the pharmaceutical, food, and cosmetic industries.
Filtration Assembly: A filtration assembly is a system used to separate solids from liquids or gases by passing the mixture through a filter medium. It typically consists of a filter housing, filter media (such as membranes or cartridges), and a means of applying pressure or vacuum to facilitate filtration. Filtration
assemblies are essential in various industries for purification, clarification, and separation processes.
Homogenizer: A homogenizer is a device used to achieve uniformity and consistency in a mixture by reducing particle size and achieving uniform distribution of components. It applies mechanical force to break down particles or droplets and create a homogeneous blend. Homogenizers are commonly used in the food, pharmaceutical, and cosmetic industries for processing liquids, suspensions, and emulsions.
Cap Sealing Machine: A cap sealing machine is used to seal caps or closures onto containers such as bottles or jars. It typically applies heat, pressure, or both to create a secure seal between the cap and the container, ensuring product integrity and preventing leakage or contamination.
Automatic Bottle Labeling Machine: An automatic bottle labeling machine is a piece of equipment used to apply labels onto bottles or other containers automatically. It can handle various types of labels, including pressure-sensitive labels, shrink sleeves, and wrap-around labels. These machines are widely used in the packaging industry to enhance product identification and branding.
Transfer Pump: A transfer pump is a device used to move liquids or slurries from one location to another within a processing system. Transfer pumps come in various designs, including centrifugal pumps, positive displacement pumps, and peristaltic pumps, and are selected based on factors such as flow rate, pressure, and the properties of the fluid being transferred. They are essential for transferring materials between different process stages, vessels, or equipment.
Injection Standard Operating Procedure (SOP) for Operation of Compounding Vessel:
This SOP provides detailed instructions for safely and efficiently operating a compounding vessel used in pharmaceutical or chemical manufacturing processes. It covers procedures for preparing the vessel, including cleaning and sanitization, loading ingredients according to specified formulations, adjusting temperature and agitation settings, monitoring the compounding process, sampling for quality control purposes, and transferring the final product for further processing or packaging. The SOP also includes guidelines for cleaning and maintenance to ensure the vessel remains in optimal condition.
Standard Operating Procedure (SOP) for Operation of Hot Air Sterilizer Thermostatically Controlled:
This SOP outlines the procedures for operating a hot air sterilizer with thermostatic control, commonly used for sterilizing laboratory equipment, glassware, and other heat-resistant materials. It includes instructions for preparing items for sterilization, loading them into the sterilizer chamber, setting and maintaining the desired temperature, monitoring the sterilization cycle, and safely removing sterilized items once the cycle is complete. The SOP also covers cleaning and maintenance tasks to ensure the sterilizer functions effectively and remains in compliance with regulatory standards.
Standard Operating Procedure (SOP) for Operation of Steam Operated Autoclave:
This SOP provides guidelines for safely and effectively operating a steam-operated autoclave, which is widely used for sterilizing equipment, media, and other materials in laboratory, healthcare, and industrial settings. It includes procedures for loading items into the autoclave chamber, selecting appropriate sterilization parameters (such as temperature, pressure, and cycle time), starting the sterilization cycle, monitoring pressure and temperature levels throughout the cycle, and safely unloading sterilized items once the cycle is complete. The SOP also covers routine maintenance tasks to ensure the autoclave operates reliably and maintains sterilization efficacy.
Standard Operating Procedure (SOP) for Operational Vial Labelling Machine: This SOP details the steps for operating a vial labelling machine, which is used to apply labels to vials or other containers in pharmaceutical, biotechnology, and healthcare industries. It includes procedures for setting up the machine, loading label rolls or sheets, adjusting label placement and orientation, initiating the labelling process, monitoring the labelling operation for accuracy and efficiency, and troubleshooting common issues. The SOP also covers cleaning and maintenance tasks to ensure the labelling machine functions effectively and produces accurately labelled vials.
Infusion Standard Operating Procedure (SOP) for Operation of Automatic Linear Vial Washing Machine: This SOP provides detailed instructions for safely and efficiently operating an Automatic Linear Vial Washing Machine. It covers procedures for preparing the machine, loading vials, selecting appropriate washing cycles, monitoring the washing process, unloading cleaned vials, and performing routine maintenance tasks to ensure the machine operates effectively.
Standard Operating Procedure (SOP) for Operation of Vial Labelling Machine: This SOP outlines the steps for operating a Vial Labelling Machine. It includes procedures for setting up the machine, loading vials, programming label specifications, initiating the labelling process, inspecting labelled vials for accuracy, and troubleshooting common issues. The SOP ensures consistent and accurate labelling of vials in compliance with regulatory standards.
Standard Operating Procedure (SOP) for Operation of Injectable Liquid Filling with Rubber Stoppering Machine: This SOP provides instructions for operating a machine used for filling injectable liquids into vials and sealing them with rubber stoppers. It covers procedures for setting up the machine, loading vials, filling them with liquid medication, inserting rubber stoppers, inspecting filled vials for defects, and maintaining the machine to ensure proper functioning.
Standard Operating Procedure (SOP) for Operation of Steris Autoclave: This SOP outlines the procedures for safely operating a Steris Autoclave, a machine used for sterilizing equipment and materials through high-pressure steam. It includes instructions for loading items into the autoclave, selecting appropriate sterilization cycles, monitoring the sterilization process, unloading sterilized items, and performing routine maintenance to keep the autoclave in optimal condition.
Standard Operating Procedure (SOP) for Operation of Material Transfer Hatch: This SOP provides guidelines for safely transferring materials between controlled environments, such as cleanrooms or sterile areas. It covers procedures for opening and closing the transfer hatch, ensuring proper airflow
and pressure differentials, disinfecting transfer equipment, and documenting transfer activities to maintain traceability and compliance with regulatory requirements.
Standard Operating Procedure (SOP) for Operation of Automatic Labeling Machine: This SOP details the steps for operating an Automatic Labeling Machine, which is used to apply labels to various products or containers. It includes procedures for setting up the machine, loading label rolls, adjusting label placement and orientation, initiating the labeling process, inspecting labeled items for quality, and troubleshooting common issues.
Standard Operating Procedure (SOP) for Operation of Compounding Vessel: This SOP provides instructions for operating a compounding vessel used in pharmaceutical or chemical manufacturing processes. It covers procedures for preparing ingredients, loading them into the vessel, mixing or blending substances according to specified formulations, monitoring temperature and agitation levels, and transferring the final product for further processing or packaging.
Standard Operating Procedure (SOP) for Operation of Conveyor Belt: This SOP outlines the procedures for safely operating a conveyor belt system used for transporting materials or products within a manufacturing or processing facility. It includes instructions for starting and stopping the conveyor, loading and unloading items, adjusting conveyor speed and direction, inspecting the belt for damage or debris, and maintaining proper alignment and tension.
Standard Operating Procedure (SOP) for Operation of Steam-operated Autoclave: This SOP provides instructions for operating a steam-operated autoclave, which is used for sterilizing equipment, media, and other materials in laboratory and healthcare settings. It covers procedures for loading items into the autoclave, selecting appropriate sterilization parameters, initiating the sterilization cycle, monitoring pressure and temperature levels, and safely unloading sterilized items once the cycle is complete.
Cream, Ointment, Gel & Lotion Operation of Tube Filling and End Sealing Machine:
a. Preparation: Ensure the machine is clean and sanitized before starting operations. Check that all necessary materials such as tubes, caps, and product are available and ready for filling. Set up the machine according to the specifications of the product being filled (tube size, filling volume, etc.).
b. Loading Tubes: Place empty tubes in the designated slot or feeder of the machine. Ensure proper alignment of tubes to avoid jams or misfeeds.
c. Filling : Start the machine and adjust the filling parameters such as speed and volume based on the product requirements. The product is pumped into the tubes through a filling nozzle. Monitoring the filling process to ensure accurate and consistent filling of each tube.
d. Sealing: Once the tubes are filled, they move to the sealing station. The sealing mechanism may vary depending on the machine design, but typically involves heat sealing or crimping the tube ends to close them securely. Check the sealed tubes for any leaks or defects.
e. Quality Control: Inspect a sample of filled and sealed tubes to ensure they meet quality standards. Adjust machine settings if necessary to address any issues identified during inspection.
f. Packaging: Once filled and sealed, the tubes are ready for packaging. They may be labeled, boxed, or otherwise prepared for shipment or distribution.
Operation of Piston Filling Machine:
a. Setup: Ensure the machine is clean and sanitized. Adjust the piston and cylinder size according to the desired fill volume. Connect the machine to a power source and any necessary utilities.
b. Priming: Prime the machine by filling the piston and cylinder with the product to be dispensed. Adjust the piston settings to control the fill volume accurately.
c. Filling: Place containers to be filled under the filling nozzle or nozzle array. Activate the machine to start the filling process. The piston moves up and down, drawing in product during the upstroke and dispensing it into containers during the downstroke. Adjust filling speed and volume as needed to ensure accurate filling.
d. Cleaning and Maintenance: After use, clean the machine thoroughly to prevent product contamination and ensure longevity. Regular maintenance tasks such as lubrication and parts replacement should be performed according to the manufacturer’s instructions.
e. Quality Control: Periodically check filled containers to ensure they meet quality standards. Adjust machine settings as necessary to address any issues identified during quality control checks.
f. Shutdown: After completing the filling process, shut down the machine following proper procedures. Clean any remaining product from the machine and prepare it for the
next use or storage.
Same Machinery in Every Section Operation of Material Transfer Hatch: A material transfer hatch is a mechanism designed to facilitate the transfer of materials between two separate areas, such as from one controlled environment to another.
The operation typically involves opening the hatch to allow access to the materials, ensuring proper sealing when closed to maintain the integrity of the environment (such as maintaining cleanliness or preventing contamination), and following any safety protocols to prevent accidents or exposure to hazardous materials.
Operation of Conveyor Belt: A conveyor belt is a continuous loop of material that moves objects from one location to another within a facility. They are commonly used in manufacturing, warehousing, and distribution applications. The operation of a conveyor belt involves loading the items onto the belt at one end, ensuring they are properly positioned to prevent jams or spills, activating the belt to move the items along its path, and unloading the items at the destination. It’s important to regularly inspect and maintain conveyor belts to ensure they operate smoothly and safely, including checking for worn or damaged components and lubricating moving parts as needed.
Operation of Laminar Air Flow Hood: A laminar airflow hood is a device used in laboratory or cleanroom
settings to provide a controlled environment free of contaminants. The operation typically involves turning on the hood to initiate the flow of filtered air, which is passed over the work area in a laminar
(parallel) flow pattern to maintain a sterile or clean environment. Users must ensure that the hood is properly calibrated and maintained to achieve the desired level of cleanliness, and they may need to wear
appropriate personal protective equipment (PPE) to prevent contamination of the workspace.
