If you are seeing wet loads in your autoclave we can help, this presentation helps show what a wet load is and why its important. It also includes some of the potential root causes of wet loads.
This document discusses methods for testing the integrity of membrane filters, specifically sterilizing-grade filters with a 0.22 μm pore size. It describes both destructive and non-destructive tests. Destructive tests involve challenging filters with bacteria to check retention ability, while non-destructive tests like the bubble point, diffusion, and pressure hold tests allow filters to be checked before and after use without compromising sterility. The bubble point test measures the minimum pressure required to force liquid out of pores and correlate to pore size. The diffusion test measures low gas flow through a wetted membrane under pressure. The pressure hold test monitors upstream pressure changes over time to detect gas diffusion.
Cleaning validation is an important process in the pharmaceutical industry to ensure product safety and purity. It involves documenting evidence that an approved cleaning procedure will adequately clean equipment used in pharmaceutical production. The cleaning validation process includes planning, execution, analytical testing, and reporting phases. A cross-functional team plans the validation program, which involves grouping products, equipment, cleaning agents, and methods. Sampling techniques like swab and rinse sampling are used in the execution phase. Acceptance criteria are established and analytical tests are performed on samples to verify cleaning levels. A validation report documents the results and conclusions to obtain approval. Revalidation may be required if any changes are made to the cleaning process.
Learn the basics of medical device development in a heavily regulated environment. No prior knowledge is needed. This is especially great for those just starting out on their careers or making a switch.
The document discusses the validation of HVAC systems in pharmaceutical facilities. It describes how HVAC systems are integral to maintaining suitable temperature, airflow, and preventing contamination. The validation of HVAC systems involves tests of air flow patterns, velocity, filtration, particles counts, temperature and humidity controls. Specific tests are outlined, including air flow testing using smoke, filter leak testing, viable particle monitoring, and recovery testing temperature and humidity levels. The methodology describes how each of these tests are performed to validate that the HVAC system is functioning properly and as intended.
Tray Dryer
Principle of Tray Dryer
Construction of Tray Dryer
Working of Tray Dryer
Qualification of Tray Dryer
Installation Qualification
Operational Qualification
Performance Qualification
References
This document provides an overview of a presentation on pharmaceutical packaging and development with a focus on pediatric formulations. It discusses choosing appropriate primary packaging, regulatory considerations, extractables and leachables testing, and packaging development processes. Specific topics covered include blister packs, bottles, closures, barrier properties of materials, desiccants, oxygen and water vapor transmission rates, and first intent guidelines.
This document summarizes a seminar presentation on validation of packaging operations. It discusses the importance of packaging for pharmaceutical products and outlines key areas of packaging validation including packaging equipment qualification and packaging process validation. Specific examples of packaging processes like blister packaging and secondary packaging are described. Critical parameters and steps for these processes are identified. The presentation provides an overview of packaging validation requirements and procedures to ensure packaging processes consistently produce pharmaceutical packages that meet quality standards.
Filter Validation and Regulatory aspectsbala murugan
Ìý
The document discusses various aspects of filter validation including:
1) Common materials used in filters include regenerated cellulose, nylon, polyamides, and polyether sulfones.
2) Porosity refers to the total empty space in a filter and affects its performance.
3) Validation tests include bacterial challenge tests, bubble point tests, and diffusion tests to evaluate a filter's effectiveness.
4) Bubble point tests determine a filter's pore size while diffusion tests measure gas flow rates through a filter.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Aseptic requirements for parenteral products".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Stability studies are conducted to prove how the quality of a drug substance or product varies over time under different environmental conditions like temperature, humidity, and light. The purpose is to determine the shelf life and appropriate storage conditions. Key factors that can affect stability include active ingredient properties, interactions, manufacturing process, dosage form, container, and storage conditions during transport and handling. Studies are done under long term, accelerated, and intermediate conditions following protocols to collect data at various time points and interpret results to establish expiration dates.
This document discusses in-process quality control of suspensions and emulsions. It defines in-process quality control as controlling manufacturing procedures from raw materials to final product packaging. Key tests for suspensions include appearance, particle size, zeta potential, viscosity, sedimentation rate and redispersibility. Maintaining proper pH, drug content uniformity and monitoring manufacturing areas are also important. Tests for emulsions include appearance, droplet size, viscosity, creaming index and phase separation. Proper documentation of quality control procedures and parameters is necessary to ensure batch uniformity and quality.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
The document summarizes the process of media fill validation for aseptic processing. It discusses key aspects of a media fill including the number and frequency of runs, choice of growth medium, number of units filled, interventions monitored, and acceptance criteria. A media fill aims to validate that the aseptic process is capable of preventing contamination under worst-case conditions. It must duplicate the manufacturing process and capture potential issues from personnel, equipment, or the environment. Successful media fills provide evidence the process is robust and can consistently produce sterile products.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
IPQC & FPQC OF OINTMENT AND OPHTHALMIC PREAPARATION.pptxBhumiSuratiya
Ìý
This document discusses IPQC and FPQC tests for ointments and ophthalmic preparations. It provides an introduction to ointments and their types, bases, advantages and disadvantages. It also discusses different types of ophthalmic preparations like eye drops, ointments, powders, inserts and lotions. The document then describes important IPQC and FPQC tests for these preparations, including tests for physical appearance, pH, spreadability, consistency, sterility, presence of metal particles, uniformity of volume, particle size, clarity and leakage. It provides details on how to perform these tests and specifies acceptance criteria.
This document provides an overview of validation practices for utilities in pharmaceutical manufacturing facilities. It discusses validation of HVAC, cleaning, water, steam, and compressed air systems. For HVAC validation, tests include air changes per hour, filter integrity, non-viable particle counts, air flow visualization, and temperature/humidity monitoring. Cleaning validation aims to demonstrate that cleaning procedures are effective by selecting worst-case products and sampling equipment surfaces. Validation ensures that utility systems reliably meet quality standards.
This document provides an overview of air handling systems (AHUs) and HVAC qualification for pharmaceutical facilities. It contains sections on introduction, types of clean rooms, principles of clean rooms, HVAC components, regulatory requirements, contamination control, air flow patterns, and HVAC qualification steps including user requirement specification, design qualification, and installation qualification. The objective is to understand the need for pharmaceutical air handling systems and their technical and qualification requirements.
This document provides an overview of lyophilization (freeze drying) technology. It defines lyophilization as a process of freezing and then reducing the amount of solvent (typically water) in a substance first through sublimation and then desorption to preserve the substance. The document outlines the principle, objectives, processing steps, advantages, disadvantages, applications, and equipment involved in lyophilization.
This document summarizes guidelines for media fill validation and USFDA process validation approaches. It discusses media fill validation, including why it is required, how to conduct media fill tests, parameters that affect sterility, and requalification requirements. It provides details on media fill procedures for liquid, powder, and lyophilized products. Frequency of media fills depends on production batch size, with more runs required for initial qualification and after certain changes. The document also introduces the USFDA's process validation lifecycle approach, which focuses on validating processes throughout the product lifecycle rather than just at startup.
This document discusses quality control tests for various pharmaceutical packaging materials. It provides details on tests for glass containers, including chemical resistance via powdered glass and water attack tests. It also describes tests for closures, such as sterility and fragmentation testing. Further tests are outlined for packaging materials like collapsible tubes, metallic tins, strips, blisters, paper and board. The document references additional sources for information on pharmaceutical packaging and quality control testing.
This presentation contains
Introduction, Advantages & Disadvantages, Process of manufacturing, Evaluation and defects in Blister, strip & ALU ALU Packaging. Useful for pharmacy students to understand the concept of blister & strip packaging
Capsules are solid dosage forms that contain a drug or mixture of drugs enclosed within a shell. The shell is typically made of gelatin but can also be other materials. Capsules are intended for oral administration and provide rapid release of contents unless they are modified or enteric release capsules. Capsules can be filled using various methods like auger, dosator, or dosing disc systems. Tests are conducted to ensure uniformity of contents, weight, and dissolution based on pharmacopeial standards.
This document provides guidance on cleanroom classifications and air quality standards for the manufacture of sterile products. It outlines four grades (A, B, C, D) for clean areas based on required airborne particulate and microbial limits. Grade A is for high-risk operations like filling and requires laminar airflow. Grades B, C, D are for less critical processes. Air quality standards are provided for "at rest" and "in operation" states. Monitoring of clean areas during production is recommended to control particulate and microbial levels.
The document discusses analytical and sampling methods used for cleaning validation in the pharmaceutical industry. It describes specific and non-specific analytical methods, such as HPLC and TOC, and the validation criteria for such methods including specificity, range, accuracy, and precision. The document also outlines different sampling techniques used to collect residues from surfaces for analysis, including direct surface sampling, swab sampling, rinse sampling, and placebo sampling. It provides details on how to properly perform each sampling method and factors to consider.
Qualification of tablet compression machinePritam Kolge
Ìý
The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.
This presentation looks at superheat in porous load autoclaves. It explains what superheat is, why superheat is a problem and identifies the causes superheat.
This document discusses high temperature sterilization methods, focusing on steam sterilization. It describes the anatomy and components of steam sterilizers, different types of steam sterilizers, and the phases of a steam sterilization cycle. The key conditions for effective steam sterilization are described as contact, time, temperature and moisture. Basic work practices are outlined for preparing items, loading and unloading sterilizers, and maintaining sterilization quality. Dry heat sterilization and special sterilization concerns are also briefly discussed.
Filter Validation and Regulatory aspectsbala murugan
Ìý
The document discusses various aspects of filter validation including:
1) Common materials used in filters include regenerated cellulose, nylon, polyamides, and polyether sulfones.
2) Porosity refers to the total empty space in a filter and affects its performance.
3) Validation tests include bacterial challenge tests, bubble point tests, and diffusion tests to evaluate a filter's effectiveness.
4) Bubble point tests determine a filter's pore size while diffusion tests measure gas flow rates through a filter.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with "Aseptic requirements for parenteral products".
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Stability studies are conducted to prove how the quality of a drug substance or product varies over time under different environmental conditions like temperature, humidity, and light. The purpose is to determine the shelf life and appropriate storage conditions. Key factors that can affect stability include active ingredient properties, interactions, manufacturing process, dosage form, container, and storage conditions during transport and handling. Studies are done under long term, accelerated, and intermediate conditions following protocols to collect data at various time points and interpret results to establish expiration dates.
This document discusses in-process quality control of suspensions and emulsions. It defines in-process quality control as controlling manufacturing procedures from raw materials to final product packaging. Key tests for suspensions include appearance, particle size, zeta potential, viscosity, sedimentation rate and redispersibility. Maintaining proper pH, drug content uniformity and monitoring manufacturing areas are also important. Tests for emulsions include appearance, droplet size, viscosity, creaming index and phase separation. Proper documentation of quality control procedures and parameters is necessary to ensure batch uniformity and quality.
This document discusses in-process quality control tests for liquid dosage forms, including sterile and non-sterile formulations. For sterile dosage forms like parenterals and ophthalmics, it describes tests for drug content, clarity, pyrogens, sterility, stability, leakage, and dye penetration. For non-sterile syrups and suspensions, it outlines testing drug content, active ingredient assays, pH, weight per ml, and particle size. The document provides details on procedures for each test and references for further information.
The document summarizes the process of media fill validation for aseptic processing. It discusses key aspects of a media fill including the number and frequency of runs, choice of growth medium, number of units filled, interventions monitored, and acceptance criteria. A media fill aims to validate that the aseptic process is capable of preventing contamination under worst-case conditions. It must duplicate the manufacturing process and capture potential issues from personnel, equipment, or the environment. Successful media fills provide evidence the process is robust and can consistently produce sterile products.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
IPQC & FPQC OF OINTMENT AND OPHTHALMIC PREAPARATION.pptxBhumiSuratiya
Ìý
This document discusses IPQC and FPQC tests for ointments and ophthalmic preparations. It provides an introduction to ointments and their types, bases, advantages and disadvantages. It also discusses different types of ophthalmic preparations like eye drops, ointments, powders, inserts and lotions. The document then describes important IPQC and FPQC tests for these preparations, including tests for physical appearance, pH, spreadability, consistency, sterility, presence of metal particles, uniformity of volume, particle size, clarity and leakage. It provides details on how to perform these tests and specifies acceptance criteria.
This document provides an overview of validation practices for utilities in pharmaceutical manufacturing facilities. It discusses validation of HVAC, cleaning, water, steam, and compressed air systems. For HVAC validation, tests include air changes per hour, filter integrity, non-viable particle counts, air flow visualization, and temperature/humidity monitoring. Cleaning validation aims to demonstrate that cleaning procedures are effective by selecting worst-case products and sampling equipment surfaces. Validation ensures that utility systems reliably meet quality standards.
This document provides an overview of air handling systems (AHUs) and HVAC qualification for pharmaceutical facilities. It contains sections on introduction, types of clean rooms, principles of clean rooms, HVAC components, regulatory requirements, contamination control, air flow patterns, and HVAC qualification steps including user requirement specification, design qualification, and installation qualification. The objective is to understand the need for pharmaceutical air handling systems and their technical and qualification requirements.
This document provides an overview of lyophilization (freeze drying) technology. It defines lyophilization as a process of freezing and then reducing the amount of solvent (typically water) in a substance first through sublimation and then desorption to preserve the substance. The document outlines the principle, objectives, processing steps, advantages, disadvantages, applications, and equipment involved in lyophilization.
This document summarizes guidelines for media fill validation and USFDA process validation approaches. It discusses media fill validation, including why it is required, how to conduct media fill tests, parameters that affect sterility, and requalification requirements. It provides details on media fill procedures for liquid, powder, and lyophilized products. Frequency of media fills depends on production batch size, with more runs required for initial qualification and after certain changes. The document also introduces the USFDA's process validation lifecycle approach, which focuses on validating processes throughout the product lifecycle rather than just at startup.
This document discusses quality control tests for various pharmaceutical packaging materials. It provides details on tests for glass containers, including chemical resistance via powdered glass and water attack tests. It also describes tests for closures, such as sterility and fragmentation testing. Further tests are outlined for packaging materials like collapsible tubes, metallic tins, strips, blisters, paper and board. The document references additional sources for information on pharmaceutical packaging and quality control testing.
This presentation contains
Introduction, Advantages & Disadvantages, Process of manufacturing, Evaluation and defects in Blister, strip & ALU ALU Packaging. Useful for pharmacy students to understand the concept of blister & strip packaging
Capsules are solid dosage forms that contain a drug or mixture of drugs enclosed within a shell. The shell is typically made of gelatin but can also be other materials. Capsules are intended for oral administration and provide rapid release of contents unless they are modified or enteric release capsules. Capsules can be filled using various methods like auger, dosator, or dosing disc systems. Tests are conducted to ensure uniformity of contents, weight, and dissolution based on pharmacopeial standards.
This document provides guidance on cleanroom classifications and air quality standards for the manufacture of sterile products. It outlines four grades (A, B, C, D) for clean areas based on required airborne particulate and microbial limits. Grade A is for high-risk operations like filling and requires laminar airflow. Grades B, C, D are for less critical processes. Air quality standards are provided for "at rest" and "in operation" states. Monitoring of clean areas during production is recommended to control particulate and microbial levels.
The document discusses analytical and sampling methods used for cleaning validation in the pharmaceutical industry. It describes specific and non-specific analytical methods, such as HPLC and TOC, and the validation criteria for such methods including specificity, range, accuracy, and precision. The document also outlines different sampling techniques used to collect residues from surfaces for analysis, including direct surface sampling, swab sampling, rinse sampling, and placebo sampling. It provides details on how to properly perform each sampling method and factors to consider.
Qualification of tablet compression machinePritam Kolge
Ìý
The document discusses the qualification process for a tablet compression machine. It describes the steps of design qualification, installation qualification, operational qualification, and performance qualification. Design qualification establishes that the machine design meets requirements. Installation qualification verifies proper installation. Operational qualification tests machine functions and settings. Performance qualification evaluates the machine's process capability at different speeds. The results showed specifications were met at an optimum speed of 40 rpm.
This presentation looks at superheat in porous load autoclaves. It explains what superheat is, why superheat is a problem and identifies the causes superheat.
This document discusses high temperature sterilization methods, focusing on steam sterilization. It describes the anatomy and components of steam sterilizers, different types of steam sterilizers, and the phases of a steam sterilization cycle. The key conditions for effective steam sterilization are described as contact, time, temperature and moisture. Basic work practices are outlined for preparing items, loading and unloading sterilizers, and maintaining sterilization quality. Dry heat sterilization and special sterilization concerns are also briefly discussed.
The document defines an autoclave as a piece of equipment used to sterilize medical instruments and equipment through the use of steam under pressure. It explains the principles of how steam penetrates and kills microorganisms. The major parts of an autoclave are identified and proper use, care, and troubleshooting are described. Testing procedures to verify the autoclave is functioning properly include the use of biological indicators.
Blast furnace process-Dry and wet coke in blast furnaceAnil Mistry
Ìý
The document discusses various issues that may arise when changing from dry to wet coke operation in a blast furnace and the process control methods needed. Specifically, it mentions screen jams, changes in coke surface properties, difficulties maintaining coke bunker levels, and potential process upsets due to changes in burden distribution, temperature control, gas control, and chemical control. It provides guidance on thermal control, gas flow control, chemical control, and definitions of an "out of control" furnace. It also summarizes the effects of potential issues like burden slips, contaminated coke bins, and low bin levels, and outlines steps operators can take to monitor and address such issues.
The document summarizes the objectives, equipment, theory, methodology, and procedures for conducting an experiment using a spray dryer. The objectives are to calculate heat effects and determine dry solids recovery efficiency. Equipment includes a spray dryer, compressor, materials like detergent and water. The methodology describes preparing a detergent slurry, collecting experimental data during startup and operation, and shut down procedures.
Fire, Pressure & Ice – Oh My! Motion Control in Hostile EnvironmentsDesign World
Ìý
Some of the most challenging and rewarding motion control applications are not made difficult because of the complexity of the machine but rather due to the hostile environments in which the application must succeed. From arctic conditions in biomedical cryogenic laboratories to the low pressure, high altitude skies that most commercial aircrafts operate, learning the particular nuances of harsh environments is a necessity to many manufacturers, machine builders, and system integrators.
Join Hack Summer of Moog Animatics as we explore some of the common (and most underestimated) hostile environments for motion control applications. Get application examples along with expert tips for designing motion control systems for hostile environments, a brief first look at Moog Animatics’ new extended range integrated motion control systems and best practices learned from over 20 years’ experience in military and commercial motion control design.
Watch this webinar to learn:
- What explosion proof really means for motion control systems?
- Which hostile environments benefit from integrated motion control systems vs. conventional motion control systems?
- Why temperature isn’t the biggest concern for aerospace applications – and what is?
- What questions to ask when buying ‘extended temperature range’ products?
This document provides information on combustion efficiency testing for oil burners. It discusses measuring draft, smoke, CO2 levels, stack and net temperatures, and using these measurements to calculate efficiency. Safety precautions are highlighted for each test. The purpose of combustion testing is to evaluate how well the unit is using fuel and should be done annually with routine service. Key steps include measuring draft, using a smoke tester to check for smoke, measuring CO2 levels with a shaker bottle, and calculating net temperature and efficiency.
Malfunctions in Solar Thermal InstallationsSekem Energy
Ìý
The document summarizes common malfunctions in solar thermal installations, including air in the system, installation failures, inadequate heat medium, improper sensor positioning, heat losses, insufficient insulation, issues with the expansion vessel, missed hot water mixing, and lack of documentation. Air in the system is one of the most frequent problems and can occur during commissioning if the system is not properly flushed of air or if an automatic deairator fails. Other common issues involve improper installation such as mixing supply and return pipes, lack of circulation prevention, and heat losses. The type and treatment of the heat medium, correct sizing and placement of system components, and comprehensive documentation are also important to avoid operational problems.
This document discusses the manufacturing and quality control of pharmaceutical aerosols. It begins by defining aerosols and their classification. It then describes the key components of an aerosol system, including propellants, containers, valves, and actuators. The two main manufacturing methods - cold filling and pressure filling - are outlined. Finally, the document details various quality control tests performed on the propellants, components, containers, and finished aerosol products to ensure quality. These include tests for leaks, spray pattern, weight, delivery rate and more.
Design Calculation of Venting for Atmospheric & Low Pressure Storage TanksKushagra Saxena
Ìý
Storage Tanks are a very important part of a petroleum Industry, This software is based on the API Std. 2000, which calculates the design of Venting and its capacity for low pressure storage & atmospheric storage tanks in case of normal venting, due to thermal changes, and in case of fire exposure.
If you are in need of this software, Kindly contact at saxena.95kushagra@gmail.com
1. Heating And Cooling In Regina, Canada
2. Heating and Cooling Specialists Information
3. Having Your Furnace Inspected
4. Furnace Repair in Regina, Canada
5. When You are in Need of Furnace Repairs
6. Furnace Inspection Is a Necessity
The document provides guidance on autoclave safety at UNC Pembroke. It discusses that autoclaving is used to treat medical waste to render it nonhazardous by eliminating pathogens through high heat and pressure. It describes the principles of how autoclaves work using steam to kill microbes. It provides details on different types of autoclaves, proper loading and use, maintenance, and testing to ensure effective sterilization. Personnel are instructed on required personal protective equipment and hazards to prevent injuries from high heat when operating autoclaves.
Ms. Samta Shah presented on evaporation, its applications in pharmaceutical industries, and various evaporation equipment. Some key points:
1. Evaporation is the process of vaporizing liquid to obtain a concentrated product using heat. It occurs below the boiling point so no boiling occurs.
2. Various evaporation equipment were discussed, including evaporating pans, vertical tube evaporators, and forced circulation evaporators. Each have different designs, principles, advantages, and uses.
3. Factors influencing evaporation include temperature, surface area, vapor pressure, agitation, and properties of the material being evaporated. Higher temperature, surface area, and vapor pressure increase evaporation rate.
Sterilization.pdf Sterilization is the complete destruction of microorganisms...Talal Albudayri
Ìý
Introduction
Sterilization is the complete destruction of
microorganisms including bacterial spores. This level
of decontamination is required for all reusable
invasive medical devices (RMD).
Ideally, sterilization methods:
• Have rapid throughput
• Are easily validated
• Are capable of processing wrapped items to
enable storage after processing without the risk of
environmental contamination of processed items.
This document discusses various drying methods and processes. It defines drying as the removal of liquid from solids using heat. Common applications of drying include manufacturing granules, reducing bulk/weight, and food preservation. The drying process involves heat transfer, phase change of water to vapor, and vapor removal. Key drying methods are described, including tray drying, vacuum drying, fluidized bed drying, and freeze drying. Tray drying uses racks and forced hot air convection. Vacuum drying uses lower pressure to reduce boiling points. Fluidized bed drying suspends materials in an upward gas flow. Freeze drying sublimes ice directly to water vapor under vacuum.
This presentation provides an in-depth analysis of structural quality control in the KRP 401600 section of the Copper Processing Plant-3 (MOF-3) in Uzbekistan. As a Structural QA/QC Inspector, I have identified critical welding defects, alignment issues, bolting problems, and joint fit-up concerns.
Key topics covered:
✔ Common Structural Defects – Welding porosity, misalignment, bolting errors, and more.
✔ Root Cause Analysis – Understanding why these defects occur.
✔ Corrective & Preventive Actions – Effective solutions to improve quality.
✔ Team Responsibilities – Roles of supervisors, welders, fitters, and QC inspectors.
✔ Inspection & Quality Control Enhancements – Advanced techniques for defect detection.
📌 Applicable Standards: GOST, KMK, SNK – Ensuring compliance with international quality benchmarks.
🚀 This presentation is a must-watch for:
✅ QA/QC Inspectors, Structural Engineers, Welding Inspectors, and Project Managers in the construction & oil & gas industries.
✅ Professionals looking to improve quality control processes in large-scale industrial projects.
📢 Download & share your thoughts! Let's discuss best practices for enhancing structural integrity in industrial projects.
Categories:
Engineering
Construction
Quality Control
Welding Inspection
Project Management
Tags:
#QAQC #StructuralInspection #WeldingDefects #BoltingIssues #ConstructionQuality #Engineering #GOSTStandards #WeldingInspection #QualityControl #ProjectManagement #MOF3 #CopperProcessing #StructuralEngineering #NDT #OilAndGas
This PDF highlights how engineering model making helps turn designs into functional prototypes, aiding in visualization, testing, and refinement. It covers different types of models used in industries like architecture, automotive, and aerospace, emphasizing cost and time efficiency.
EXPLORE 6 EXCITING DOMAINS:
1. Machine Learning: Discover the world of AI and ML!
2. App Development: Build innovative mobile apps!
3. Competitive Programming: Enhance your coding skills!
4. Web Development: Create stunning web applications!
5. Blockchain: Uncover the power of decentralized tech!
6. Cloud Computing: Explore the world of cloud infrastructure!
Join us to unravel the unexplored, network with like-minded individuals, and dive into the world of tech!
Integration of Additive Manufacturing (AM) with IoT : A Smart Manufacturing A...ASHISHDESAI85
Ìý
Combining 3D printing with Internet of Things (IoT) enables the creation of smart, connected, and customizable objects that can monitor, control, and optimize their performance, potentially revolutionizing various industries. oT-enabled 3D printers can use sensors to monitor the quality of prints during the printing process. If any defects or deviations from the desired specifications are detected, the printer can adjust its parameters in real time to ensure that the final product meets the required standards.
Welcome to the March 2025 issue of WIPAC Monthly the magazine brought to you by the LinkedIn Group WIPAC Monthly.
In this month's edition, on top of the month's news from the water industry we cover subjects from the intelligent use of wastewater networks, the use of machine learning in water quality as well as how, we as an industry, need to develop the skills base in developing areas such as Machine Learning and Artificial Intelligence.
Enjoy the latest edition
2. What isawetload?
• When an autoclave load is removed from the
chamber, the load must be dry. In moist
environments microbial growth can occur.
• Dryness is difficult to define though, so at
what level is any condensate acceptable?
At Thermal Compliance we define it as, if
condensate can be detected by the senses, it is
not acceptable. Therefore you must not:
• See it
• Feel it
3. Autoclave
Basic overview of how a Porous Load Steam Steriliser works
Steam pressure is controlled to ensure
the drain is the correct temperature.
Baffle plates force steam to displace air
down the drain.
Condensate will collect if not allowed to free drain.
4. Potential Causes
Wet loads can be caused by several factors:
Steam Distribution / Steam Quality Issues
• Failed Steam Traps
• Steam Generator Issues
Autoclave
• Jacket Temperature
• Vacuum Pump Issues
• Fans. Pipework on Roof of Chamber
Load Design and Preparation
• Change in Load Wrapping
• Load Item Materials of Construction
• Poor Load Orientation
• Poor Load Wrapping
5. Potential Causes
Steam Distribution / Steam Quality
Step 1
Perform Steam Quality Testing (EN285:2015, PDA Technical Report 1)
• At Point of Use
• At Point of Generation
Step 2
Perform a Distribution Survey
• Check Steam Traps
• Pipe levels etc
6. Potential Causes
Load Design and Preparation
Ensure the bags used for wrapping
are specified correctly, ensure they
are:
• The right size for your items
• The right shape for your items
Load Wrapping
Cut bags to Size
Use suitable Size bags
Don’t fold over bags
Remove Excess
Wrap
Orientate the load to:
• Allow free draining
• Place large items on the bottom
shelf
• Consider where condensate
would be generated and how to
remove it
Orientation of Load
Paper/Plastic Bags should be
orientated with paper adjacent to
paper and plastic adjacent to plastic.
Bag placement
7. Potential Causes
Autoclave
The Jacket temperature should be below
sterilisation temperature. To allow
condensate to form and go to drain.
High Temperatures may cause superheat
and low temperatures may cause
condensate to rain onto the load.
Vacuum Pump
Check feed water temperature
Check pulse times and depths.
Does the wet load
correlate to ports, fans etc
in the Autoclave Roof?
8. 0201
ABOUT US
We deliver practical and online
training courses in:
• Autoclave Validation
• Temperature Mapping
• Steam Quality Testing
• Kaye Validator 2000
Training
We can help with:
• Wet Loads
• Superheat Investigations
• Equilibration Failures
• Steam Quality Failures
• Biological Indicator Failures
Consultancy 03We perform Validation on a
wide range of equipment:
• LN2 Freezers – Ovens
• Autoclaves and SIP
• Freeze Driers
• Dry Heat Processes
Validation
9. CONTACT US
Chris Maughan
Managing Director
Thermal Compliance
chrism@thermalcompliance.co.uk
www.thermalcompliance.co.uk
18 Harelands Courtyard Offices
Moor Road Melsonby
Richmond
DL10 5NY
UK
Tel +44 (0)1748 327 247
www.thermalcompliance.com
(Training Website)