The document discusses Telstar's Pura range of sterility test isolators. It notes that ergonomic trials are performed early in development to prevent issues. The Pura range was developed using this process and 3D modeling software. Features of the Pura isolators include various chamber sizes, glove ports, materials compatible with hydrogen peroxide sterilization, and options like monitoring sensors and shelving. The isolators are designed to avoid false positive sterility test results from contamination and provide a reliable aseptic environment.
Esco Containment Barrier Isolator (CBI) facilitates the isolation of a product or process while providing the required conditions for a sterile/ aseptic environment. It is configured to operate at positive or negative pressure. This equipment provides a comprehensive range of personnel
and product protection in addition to protection for the surrounding work areas and the environment.
CBI's design has complete compliance to PIC/s and EU cGMP standardswith its 19 mm radius coved internal corners in a single piece chamber (no perforations or grilles for contaminants to be trapped on all 4 corners). Its Rear Return Filter ensures that ducts are not contaminated. The system comes in either recirculatory or single pass airflow.
Applications
• Pharmacy Compounding (Chemotherapy/TPN)
• As a Class III Cabinet for Biosafety Levels (BSL) 3 and 4
• Small Batch Sterility Testing
• Small-scale Potent Material Handling
• Cell Processing
• Aseptic Processing
• Research and Development
MadgeTech’s Ethylene Oxide (EtO) sterilization data loggers can be used to monitor, record and validate sterilization cycles. These rugged devices are capable of withstanding temperatures up to 80 °C, and are available in a temperature or temperature and humidity model. The EtO sterilization data loggers record measurements at a user-selectable interval, providing validation for the entire cycle. The MadgeTech software makes it easy to create validation reports and prove compliance with federal regulations.
Precision water vapour permeability analysis of medical
& pharmaceutical packaging. Permeability testing is used in the design
and manufacture of blister packs, bottles,
pill containers, surgical dressings, needles
and syringe products.
SLK Technosystems was founded in the year 2006 to meet requirements of various organizations in the field of PVC ID Cards and Smart Card Solutions. The initial business activity concentrated on Smart Card Solutions, manufacture of Card Fusing Machines, ID Cards and Card Die-Cutters.
Esco Isotherm Laboratory Ovens and IncubatorsEsco Group
Laboratory ovens are used for high-forced volume thermal convection applications. These ovens generally provide uniform temperatures throughout. Process applications for laboratory ovens can be for annealing, die-bond curing, drying, Polyimide baking, sterilizing, and other industrial laboratory functions. Typical sizes are from one cubic foot (28 liters) to 32 cubic feet (906 liters) with temperatures that can reach 300°C (572°F).
Laboratory incubator is an equipment for controlling the temperature, humidity, and other conditions in which a microbiological culture is being grown. Typical incubators are
insulated boxes with an adjustable heater, going up to 60°C to 65°C (140°F to 149°F), though some can go slightly higher (generally to no more than 100°C). Incubators can vary in size from tabletop to units the size of small rooms. As for temperature, most commonly used is approximately 36°C to 37°C (97°F to 99°F).
Incubator are designed to maintain 20°C necessary to perform a test called a Biochemical Oxygen Demand (BOD). It involves incubating samples saturated with oxygen at 20°C
usually for five days. Incubators designed to maintain temperatures below ambient to as low as about 10°C are
generally called low temperature incubators.
EtO sterilization is an alternative to high temperature steam sterilization found in medical and pharmaceutical industries. EtO sterilization validation or testing allows users to accurately sterilize and maintain regulatory requirements. Rugged and durable, MadgeTech’s EtO data loggers makes retrieving data fast and easy to use.
Esco Containment Barrier Isolator (CBI) facilitates the isolation of a product or process while providing the required conditions for a sterile/ aseptic environment. It is configured to operate at positive or negative pressure. This equipment provides a comprehensive range of personnel
and product protection in addition to protection for the surrounding work areas and the environment.
CBI's design has complete compliance to PIC/s and EU cGMP standardswith its 19 mm radius coved internal corners in a single piece chamber (no perforations or grilles for contaminants to be trapped on all 4 corners). Its Rear Return Filter ensures that ducts are not contaminated. The system comes in either recirculatory or single pass airflow.
Applications
• Pharmacy Compounding (Chemotherapy/TPN)
• As a Class III Cabinet for Biosafety Levels (BSL) 3 and 4
• Small Batch Sterility Testing
• Small-scale Potent Material Handling
• Cell Processing
• Aseptic Processing
• Research and Development
MadgeTech’s Ethylene Oxide (EtO) sterilization data loggers can be used to monitor, record and validate sterilization cycles. These rugged devices are capable of withstanding temperatures up to 80 °C, and are available in a temperature or temperature and humidity model. The EtO sterilization data loggers record measurements at a user-selectable interval, providing validation for the entire cycle. The MadgeTech software makes it easy to create validation reports and prove compliance with federal regulations.
Precision water vapour permeability analysis of medical
& pharmaceutical packaging. Permeability testing is used in the design
and manufacture of blister packs, bottles,
pill containers, surgical dressings, needles
and syringe products.
SLK Technosystems was founded in the year 2006 to meet requirements of various organizations in the field of PVC ID Cards and Smart Card Solutions. The initial business activity concentrated on Smart Card Solutions, manufacture of Card Fusing Machines, ID Cards and Card Die-Cutters.
Esco Isotherm Laboratory Ovens and IncubatorsEsco Group
Laboratory ovens are used for high-forced volume thermal convection applications. These ovens generally provide uniform temperatures throughout. Process applications for laboratory ovens can be for annealing, die-bond curing, drying, Polyimide baking, sterilizing, and other industrial laboratory functions. Typical sizes are from one cubic foot (28 liters) to 32 cubic feet (906 liters) with temperatures that can reach 300°C (572°F).
Laboratory incubator is an equipment for controlling the temperature, humidity, and other conditions in which a microbiological culture is being grown. Typical incubators are
insulated boxes with an adjustable heater, going up to 60°C to 65°C (140°F to 149°F), though some can go slightly higher (generally to no more than 100°C). Incubators can vary in size from tabletop to units the size of small rooms. As for temperature, most commonly used is approximately 36°C to 37°C (97°F to 99°F).
Incubator are designed to maintain 20°C necessary to perform a test called a Biochemical Oxygen Demand (BOD). It involves incubating samples saturated with oxygen at 20°C
usually for five days. Incubators designed to maintain temperatures below ambient to as low as about 10°C are
generally called low temperature incubators.
EtO sterilization is an alternative to high temperature steam sterilization found in medical and pharmaceutical industries. EtO sterilization validation or testing allows users to accurately sterilize and maintain regulatory requirements. Rugged and durable, MadgeTech’s EtO data loggers makes retrieving data fast and easy to use.
Esco Evidence Drying Cabinet is a negative pressure cabinet designed to provide security, tamper proof, and prevent loss of integrity and credibility and possible cross-contamination of evidence and impede any harmful airborne pathogens, putrid odors, and other gases from escape that may harm or infect employees/technicians.
IRIS is a radiopharmaceutical injector that performs calibrated injections to patients, starting from a multi-dose solution of FDG or other radiopharmaceuticals.
Metal detection and x ray inspection of foodTechno Service
توفر شركة تكنوسيرفيس مجموعة أجهزة الكشف عن المعادن Thermo Scientific ™ Sentinel ™ والتي تتميز بأداء كشف عالي الحساسية لجودة منتجك ومدي احتمالية العثور على ملوثات معادن حديدية وغير حديدية وأي ملوثات في الأطعمة والمشروبات وغيرها من المنتجات.
باستخدام تقنيات مبتكرة مثل Multiscan ™ و Selectscan ™ ، تساعد أجهزة الكشف عن المعادن Sentinel الشركات المصنعة على زيادة سلامة وصحة العملاء وتحسين جودة المنتج وزيادة كفاءة الإنتاج.
اكتشف معنا كيف يمكن لمجموعة منتجات Sentinel تلبية احتياجات تطبيقاتك.
أهمية وجود أجهزة الكشف المعادن في خط إنتاجك ؟
1️⃣ أصبح الآن من الشروط الأساسية لدي منظمة الصحة والأغذية لحمايه المستهلك.
2️⃣ ضروري لمنح شهادة الأيزو لمنتجك
3️⃣ ضمان استمرارية البراند الخاص بك في السوق وحصوله علي سمعة طيبة نتيجة ضمان الجودة
تستخدم هذه الاجهزه على خطوط انتاج وتعبئه الاغذيه
(مثل المطاحن و مصانع الالبان والحلويات والبسكويت والشيكولاته والمكرونه والمخللات والخضروات والفواكه المجمده والايس كريم ..وغيرها)
مميزات الجهاز:
◀يمكنه الكشف عن المعادن داخل منتجك خلال مراحل عمليه التصنيع حتى التعبئه وبدقه عاليه
◀ يمكنه رفض كل المنتجات المخالفه لمعايير الجوده وسلامه الغذاء
◀ يتميز الجهاز بالشكل الانسيابي وصغر الحجم
◀الجهاز حاصل على شهاده من هيئه سلامه الغذاء FDA
◀ الجهاز حاصل على IP69K لمقاومه الماء
◀ السير مصنوع من اعلى الخامات جوده والتي تتحمل الاوزان الكبيره
◀ سهل برمجته والتدريب عليه وتوافر قطع الغيار والصيانه
◀ ضمان لمده عام كامل
◀ الجهاز به إنذار صوت وضوء
◀ مهندسين متخصصين للتركيب والتدريب علي الجهاز وحاصلين علي شهادات معتمدة من ThermoFisher
تطبيقات اجهزه الكشف عن المعادن والشوائب :
تستهدف اجهزه الكشف عن المعادن والشوائب (metal detectors وال x-ray) كل شركات ومصانع الاغذيه وقطاع سلامه الغذاء وخطوط الانتاج التي تسعى للحصول على شهادات الايزو والجوده .
تسعى تكنوسيرفيس لخدمه جميع عملائها باحترافيه عن طريق مساعدتهم للوصول للنجاح في جميع المجالات السابقه .
just call us 01116593835
http://technoservice-egypt.com/
Sterilization Validation for Medical DevicesDocKetchum
Every medical device produced must be sterilized before being shipped to hospitals, doctors’ offices, and other medical locations.
Random samples of these devices must then be tested to be sure the sterilization kills disease causing microbes including bacteria, fungus, and spores in every device.
These are some of the most common ways that sterilization validation is performed.
Pharmaceutical Isolator technology in aseptic processingPalash Das
These articles describe different aspects of aseptic processing Isolator.
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half- suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling. The earliest uses of aseptic isolators were for sterility testing. Sterility test isolators make up most of the aseptic isolators in use and are available in many different sizes and configurations. Sterility test isolators do not need to be installed in a classified area. No formal requirement exists for a Grade D environment, but the area should be controlled to allow only trained personnel.
Esco HP Series Laboratory Refrigerators and FreezersEsco Group
Esco HP Series refrigerators and freezers are designed for laboratory use offering superior product protection with long term reliability and exceptional product quality. When superior levels of cold storage performance, reliability, and flexibility are needed, the ESCO HP series of Laboratory Refrigerators and Freezers is the best choice—it provides a high performance protection for your precious samples!
Laboratory refrigerators and freezers are generally used for storing non-volatile reagents and non-volatile biological specimens and are usually marketed through laboratory equipment supply store. The temperature ranges from +2°C to +15°C for refrigerators and –10°C to –40°C for freezers. Also has wide range of capacity on HC6-700S:170 L for refrigerator and 160 L for freezer; HC6-700S: 260 L for refrigerator and 265 L for freezer.
The Esco Cytoculture Cytotoxic Safety Cabinet is the premium solution for cytotoxic/antineoplastic drug processing, providing the highest level of patient, pharmacist and environmental protection. This revolutionary product builds on Esco’s experience of more than 20 years as a global leader in biological safety containment technology.
The unique demands of handling and preparing cytotoxic drugs for use in chemotherapy require a specialized cabinet. As cytotoxic drugs cannot be inactivated by chemical decontamination, Class II biosafety cabinets should not be used. With this in mind, Esco has developed a highly specialized range of cabinets designed especially for handling these potentially dangerous drugs.
Key Benefits:
-Safe filter changing
-Safer dual exhaust filters
-HPA certified to EN 12469
Cleanroom garments can accumulate contamination during storage and between laundry washes, which in turn may lead to lower product yields and increased product quality issues.
Esco garment storage cabinets make a positive contribution to maintaining the cleanliness of a cleanroom environment.
• ULPA-filtered airflow keeps garments clean in storage and when being handled.
• Enables garments to be stored in a visible and organized manner.
• This small investment emphasizes to both employees and visitors that the garment they are about to don will be used to enter a controlled environment, which leads to a better awareness of cleanroom standards and operating procedures.
Quality System Expectations : Single-Use Materialsgueste42f6b5
Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
A short presentation on containments which is used for potent drug manufacturing facilities and labs also these are used in biotechnology industries.
Very useful for BSL facility and Oncology/Hormones/Esteroids manufacturing and research.
We are an ISO 9001:2008 Certified Company established in 2009 manufactures high quality plastic labware with excellent service levels through proper accreditation and certification. We make superior quality laboratory plasticwares of International standard using virgin production material under stringent quality control conditions. Our product range has been segregated in seven different sub-categories that include Centrifuge Ware, Liquid Handling Consumables, Cryo Ware, Multipuprpose Racks & Boxes, General Laboratory Products, Microscopy Family and Organizers. New products across all sub categories that include Microscopy products, Racked & Refill Pipette tips, unique range of rotator and multi-combination racks together with high quality Cryogenic Vials.
Our product range find place in all kind of laboratories located worldwide. They are further extensively used in below categories:
Universities
Research Institutes
Environmental testing labs (sampling)
Clinical Research Labs
Clinical Diagnostic Labs
Forensic Science Labs
Public Health Labs
Bio repositories (Especially Specimen containers)
Micro Biology Labs
Biotechnology Labs
Life Science Labs
Stem Cell Research
Hospital & Diagnostic centres
Industrial Labs
A. Pharmaceuticals
B. Food Beverage (Quality, R&D, Manufacturing process labs)
C. Chemical Petroleum processEnvironment and Process Control IndustriesSchool & College Labs.
To know more visit our website www.abdoslabware.com
11-03-2010 El Gobernador Guillermo Padrés visitó las instalaciones de la plan...Guillermo Padrés Elías
Hermosillo, Sonora; La calidad de los procesos de producción ensamblado y estampado de Ford Hermosillo fue reconocida por el Gobernador Guillermo Padrés Elías quien en visita a las instalaciones de la planta destacó la fuerza laboral y el talento de los sonorenses.
Esco Evidence Drying Cabinet is a negative pressure cabinet designed to provide security, tamper proof, and prevent loss of integrity and credibility and possible cross-contamination of evidence and impede any harmful airborne pathogens, putrid odors, and other gases from escape that may harm or infect employees/technicians.
IRIS is a radiopharmaceutical injector that performs calibrated injections to patients, starting from a multi-dose solution of FDG or other radiopharmaceuticals.
Metal detection and x ray inspection of foodTechno Service
توفر شركة تكنوسيرفيس مجموعة أجهزة الكشف عن المعادن Thermo Scientific ™ Sentinel ™ والتي تتميز بأداء كشف عالي الحساسية لجودة منتجك ومدي احتمالية العثور على ملوثات معادن حديدية وغير حديدية وأي ملوثات في الأطعمة والمشروبات وغيرها من المنتجات.
باستخدام تقنيات مبتكرة مثل Multiscan ™ و Selectscan ™ ، تساعد أجهزة الكشف عن المعادن Sentinel الشركات المصنعة على زيادة سلامة وصحة العملاء وتحسين جودة المنتج وزيادة كفاءة الإنتاج.
اكتشف معنا كيف يمكن لمجموعة منتجات Sentinel تلبية احتياجات تطبيقاتك.
أهمية وجود أجهزة الكشف المعادن في خط إنتاجك ؟
1️⃣ أصبح الآن من الشروط الأساسية لدي منظمة الصحة والأغذية لحمايه المستهلك.
2️⃣ ضروري لمنح شهادة الأيزو لمنتجك
3️⃣ ضمان استمرارية البراند الخاص بك في السوق وحصوله علي سمعة طيبة نتيجة ضمان الجودة
تستخدم هذه الاجهزه على خطوط انتاج وتعبئه الاغذيه
(مثل المطاحن و مصانع الالبان والحلويات والبسكويت والشيكولاته والمكرونه والمخللات والخضروات والفواكه المجمده والايس كريم ..وغيرها)
مميزات الجهاز:
◀يمكنه الكشف عن المعادن داخل منتجك خلال مراحل عمليه التصنيع حتى التعبئه وبدقه عاليه
◀ يمكنه رفض كل المنتجات المخالفه لمعايير الجوده وسلامه الغذاء
◀ يتميز الجهاز بالشكل الانسيابي وصغر الحجم
◀الجهاز حاصل على شهاده من هيئه سلامه الغذاء FDA
◀ الجهاز حاصل على IP69K لمقاومه الماء
◀ السير مصنوع من اعلى الخامات جوده والتي تتحمل الاوزان الكبيره
◀ سهل برمجته والتدريب عليه وتوافر قطع الغيار والصيانه
◀ ضمان لمده عام كامل
◀ الجهاز به إنذار صوت وضوء
◀ مهندسين متخصصين للتركيب والتدريب علي الجهاز وحاصلين علي شهادات معتمدة من ThermoFisher
تطبيقات اجهزه الكشف عن المعادن والشوائب :
تستهدف اجهزه الكشف عن المعادن والشوائب (metal detectors وال x-ray) كل شركات ومصانع الاغذيه وقطاع سلامه الغذاء وخطوط الانتاج التي تسعى للحصول على شهادات الايزو والجوده .
تسعى تكنوسيرفيس لخدمه جميع عملائها باحترافيه عن طريق مساعدتهم للوصول للنجاح في جميع المجالات السابقه .
just call us 01116593835
http://technoservice-egypt.com/
Sterilization Validation for Medical DevicesDocKetchum
Every medical device produced must be sterilized before being shipped to hospitals, doctors’ offices, and other medical locations.
Random samples of these devices must then be tested to be sure the sterilization kills disease causing microbes including bacteria, fungus, and spores in every device.
These are some of the most common ways that sterilization validation is performed.
Pharmaceutical Isolator technology in aseptic processingPalash Das
These articles describe different aspects of aseptic processing Isolator.
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. The operator can perform tasks through half- suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator as with aseptic processes, or protect the operator from the product as with potent product handling. The earliest uses of aseptic isolators were for sterility testing. Sterility test isolators make up most of the aseptic isolators in use and are available in many different sizes and configurations. Sterility test isolators do not need to be installed in a classified area. No formal requirement exists for a Grade D environment, but the area should be controlled to allow only trained personnel.
Esco HP Series Laboratory Refrigerators and FreezersEsco Group
Esco HP Series refrigerators and freezers are designed for laboratory use offering superior product protection with long term reliability and exceptional product quality. When superior levels of cold storage performance, reliability, and flexibility are needed, the ESCO HP series of Laboratory Refrigerators and Freezers is the best choice—it provides a high performance protection for your precious samples!
Laboratory refrigerators and freezers are generally used for storing non-volatile reagents and non-volatile biological specimens and are usually marketed through laboratory equipment supply store. The temperature ranges from +2°C to +15°C for refrigerators and –10°C to –40°C for freezers. Also has wide range of capacity on HC6-700S:170 L for refrigerator and 160 L for freezer; HC6-700S: 260 L for refrigerator and 265 L for freezer.
The Esco Cytoculture Cytotoxic Safety Cabinet is the premium solution for cytotoxic/antineoplastic drug processing, providing the highest level of patient, pharmacist and environmental protection. This revolutionary product builds on Esco’s experience of more than 20 years as a global leader in biological safety containment technology.
The unique demands of handling and preparing cytotoxic drugs for use in chemotherapy require a specialized cabinet. As cytotoxic drugs cannot be inactivated by chemical decontamination, Class II biosafety cabinets should not be used. With this in mind, Esco has developed a highly specialized range of cabinets designed especially for handling these potentially dangerous drugs.
Key Benefits:
-Safe filter changing
-Safer dual exhaust filters
-HPA certified to EN 12469
Cleanroom garments can accumulate contamination during storage and between laundry washes, which in turn may lead to lower product yields and increased product quality issues.
Esco garment storage cabinets make a positive contribution to maintaining the cleanliness of a cleanroom environment.
• ULPA-filtered airflow keeps garments clean in storage and when being handled.
• Enables garments to be stored in a visible and organized manner.
• This small investment emphasizes to both employees and visitors that the garment they are about to don will be used to enter a controlled environment, which leads to a better awareness of cleanroom standards and operating procedures.
Quality System Expectations : Single-Use Materialsgueste42f6b5
Single-Use technologies supply materials to the biomanufacturing process that replace the need for stainless steel and traditional manufacturing processes which require extensive validation and process development.
A short presentation on containments which is used for potent drug manufacturing facilities and labs also these are used in biotechnology industries.
Very useful for BSL facility and Oncology/Hormones/Esteroids manufacturing and research.
We are an ISO 9001:2008 Certified Company established in 2009 manufactures high quality plastic labware with excellent service levels through proper accreditation and certification. We make superior quality laboratory plasticwares of International standard using virgin production material under stringent quality control conditions. Our product range has been segregated in seven different sub-categories that include Centrifuge Ware, Liquid Handling Consumables, Cryo Ware, Multipuprpose Racks & Boxes, General Laboratory Products, Microscopy Family and Organizers. New products across all sub categories that include Microscopy products, Racked & Refill Pipette tips, unique range of rotator and multi-combination racks together with high quality Cryogenic Vials.
Our product range find place in all kind of laboratories located worldwide. They are further extensively used in below categories:
Universities
Research Institutes
Environmental testing labs (sampling)
Clinical Research Labs
Clinical Diagnostic Labs
Forensic Science Labs
Public Health Labs
Bio repositories (Especially Specimen containers)
Micro Biology Labs
Biotechnology Labs
Life Science Labs
Stem Cell Research
Hospital & Diagnostic centres
Industrial Labs
A. Pharmaceuticals
B. Food Beverage (Quality, R&D, Manufacturing process labs)
C. Chemical Petroleum processEnvironment and Process Control IndustriesSchool & College Labs.
To know more visit our website www.abdoslabware.com
11-03-2010 El Gobernador Guillermo Padrés visitó las instalaciones de la plan...Guillermo Padrés Elías
Hermosillo, Sonora; La calidad de los procesos de producción ensamblado y estampado de Ford Hermosillo fue reconocida por el Gobernador Guillermo Padrés Elías quien en visita a las instalaciones de la planta destacó la fuerza laboral y el talento de los sonorenses.
The Law Office of Michael Hsueh is dedicated to helping you protect your rights in the workplace and exclusively represents employees who have been victims of workplace discrimination, retaliation, sexual harassment, and wrongful termination. The firm prides itself on its highly individualized and client-oriented approach to litigation.
Performance Characteristics of SEIGUsed In Wind Energy Conversion SystemIJSRD
This paper shows the wind driven self-excited induction generator used in wind turbine for drive applications. The self-excited induction generator is mathematically modeled to perform efficiently as a real time performance. Here we used voltage source inverter which is a normal pulse width modulation inverter fed with resistive load. A voltage source inverter is used which forms a bridge between the self-excited induction generator and a load .The voltage source inverter are used to provide to make a system simple and cost effective. The simple arrangement is used such that the efficiency of the system becomes high with minimized losses. The PWM Inverters (VSI) is used to convert the variable magnitude and frequency voltage into reliable constant voltage and constant frequency supply to drive the isolated load. The self-excited induction generator and other power electronic converter components are modeled through coding and simulation in MATLAB/SIMULINK 8.1.604 (R2013a).
Magnetrol is a globally recognized manufacturer of level and flow measurement instrumentation and devices. Technologies include inferential and direct measurement.
Appreciated by customers across the nation for supplying, trading and wholesaling a broad array of high quality pharmaceutical hygiene & cleanRoom
products, June Enterprises started its operations in December 2013.
In a short span of time, the company expanded its breadth of operations to provide CleanRoom Products to the Indian pharmaceutical industry &
neighboring countries.
The product range offered by June Enterprises includes: – Sterilization Monitoring & Validation Products, ATCC Culture, Cleanroom Garments &
Accessories, Cleanroom Supplies, Critical Cleaning Products, Products for Food & Facilities, Sterilization Packaging & Sealing Products, Products for
Stores & Warehouses, USP Class Silicone Tubing among others.
In order to ensure high standards of quality, the offered range of Cleanroom Products is procured and sourced from trusted and reliable Leaders in their
® ® respective product ranges for example Sterilization Products by Mesa Labs, Cleaning & disinfectants by Contec & ATCC by Microbiologics.
With years of experience, expertise and a proven track-record of helping many companies with its CleanRoom Products & Sterilization needs, June
Enterprises has established an enviable position in the PHARMA, FOOD & HOSPITAL segments.
JUNE Enterprises is an ISO 9001:2015 certified company.
Learn More: https://www.juneenterprises.com/
Esco Pharma Laminar Flow Straddle Units, Single and DoubleEsco Group
Esco Enterprise Laminar Flow Straddle Units are designed for larger-scale process protection in industrial applications typically requiring multiple units connected in an assembly line configuration. They may be placed within an ISO Class 8 cleanroom to provide an ultra-clean environment directly at the process level, without the initial and operating costs associated with a full-sized ISO Class 3 or 4 cleanroom.
We are one of the fastest growing Manufacturer, service provider and Supplier firms providing added value in its offered superior quality HVAC & Clean Room Solutions. Apart from the industry proven design of our products.
Implementing and Managing Pre-use Post-sterilization Integrity Testing (PUPSIT)MilliporeSigma
This presentation explores best practices and case studies in aseptic processing, including how to implement and manage PUPSIT. You will learn:
• Integrity Testing – the background on IT itself, why it is important, and how it works
• Filtration setups and single-use technology
• The PUPSIT debate and how PUPSIT can be achieved with current technology, final filling, formulation, filtration
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.emdmillipore.com/remotevisit
Implementing and Managing Pre-use Post-sterilization Integrity Testing (PUPSIT)Merck Life Sciences
This presentation explores best practices and case studies in aseptic processing, including how to implement and manage PUPSIT. You will learn:
• Integrity Testing – the background on IT itself, why it is important, and how it works
• Filtration setups and single-use technology
• The PUPSIT debate and how PUPSIT can be achieved with current technology, final filling, formulation, filtration
To learn more about this topic or collaborate with our technical experts, schedule a remote visit at our M Lab™ Collaboration Centers: www.merckmillipore.com/remotevisit
The Esco General Processing Platform Isolator (GPPI) is a highly adaptable, unidirectional laminar airflow isolator that can be used for sterility testing or other processes that require an ISO Class 5 (Grade A) aseptic environment. The GPPI’s advanced control system allows the operator to select either positive or negative chamber pressure as well as single pass or recirculating airflow patterns. These features, along with the ability to perform safe change procedures on the supply and return ULPA filters, make the GPPI a highly versatile isolator that can be used for potent or non-potent aseptic materials.
In addition, the Esco GPPI’s design offers over 20 standard options and configurations ensuring that Esco can provide a standard solution to fit your specific process and facility requirements. Should a standard option not fit your requirements Esco can offer customized solutions as well.
The retractable housings are intended solely for measurement tasks in conjunction with the specified METTLER TOLEDO electrodes/sensors, namely pH and redox (ORP) combined electrodes as well as dissolved oxygen (DO) or conductivity sensors.
2. A leading pharmaceutical company report stated almost 25%
of all lost time illnesses were caused by ergonomic related
issues.
Telstar put great emphasis on the need to perform ergonomic
trials, at the onset of all projects, to identify issues and prevent
them becoming a problem. Models together with trials serve
to simulate the process operations involved.
This process has already been extensively performed in the
development of the Telstar Pura range of Sterility Test Isolators,
resulting in an ergonomically designed range.
Supported by continual investment in 3D software technology
operated by design personnel from a highly qualified
engineering background. 3D design provides a clearer
visualisation of the entire project preventing clashes and
accurate production of 2D drawing elevations.
As an international leader focused on Quality, Telstar partners
with clients to provide technically advanced solutions on a
global basis through innovation, absolute reliability and expert
project management.
Providing in-house expertise in design (strengthened with
3D design skills) and manufacture of innovative/bespoke
Barrier Isolation equipment, which requires research and
development skills on a day-to-day basis.
Telstar strives continuously to address and adapt to ever
changing industry needs, evolving inline with government
regulations and stringent industry standards.
Recognised Leaders in Sterility Testing Technology
Telstar rises to demands in pharmaceutical Aseptic and Containment Barrier Isolation equipment, providing solutions for specific
challenges presented by clients’ individual requirements.
Sterility Testing is an ever more important part of any pharmaceutical process. A clear understanding of the process is paramount
to its success.
Telstar Life Sciences UK Ltd, is the centre of excellence for the Aseptic and Containment Barrier Isolation side of the Telstar
business and are fully aware that attention to detail makes all the difference when designing the right solution.
3. ionHP®
Following extensive research Telstar UK has identified an alternative decontamination
system, using (ionized Hydrogen Peroxide) ionHP®.
This bio-decontamination system is an integrated decontamination system dedicated
to a single Sterility Test Isolator.
This unique system provides rapid and effective sterilisation of the Isolator and is
proven technology giving a six log reduction of viruses, spores and fungi.
The system produces a fine mist of hydrogen peroxide and isopropyl alcohol by
passing through a cold plasma arc to ionize the medium. Once ionized it acts like a
gas providing excellent distribution and due to its positive charged properties reaches
those hard to reach areas. This in turn reduces the sterilisation times over alternative
methods.
The ionHP® system is controlled via
the Isolator PLC based control system
and includes complete data acquisition
and H202 chamber monitoring.
The ionHP® Advantage
99 Superior efficacy
99 Rapid response and reduced cycle times
99 Reduced Sterilant quantities
99 No excessive temperature rise during cycle
99 Temperature & Humidity has no effect on the cycle
99 Excellent materials compatibility
99 Minimized downtime
99 Environmentally-friendly (“green”)
99 Cost-effective pricing
A comprehensive range protecting the most critical step in the production process…
Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production
batch. It is an essential element of sterilisation validation and it must be performed in a manner which avoids the risks of both
false positive and false negative results.
False positive results are generally due to laboratory contamination from the
testing environment or technician/technique error and cause additional work
in terms of extra documentation required and adds significantly to cost as it
delays or prevents release of the product for sale.
Telstar Pura Sterility Test Isolators are designed to avoid the risk of false results
and to protect the product from both the process and externally generated
factors that would compromise its quality.
The Telstar Pura range has been developed to cover a wide range of client’s
needs. The units’ ability to provide a reliable aseptic environment for sterility
testing and other aseptic processes is unquestioned. A minimum of log
6 reduction in spore forming micro-organisms is consistently achieved &
validated using a BI challenge.
The Telstar Pura range is suitable for performing both Direct Inoculation and
Filter Membrane sterility tests with flexibility to be bio-decontaminated by
different types of systems available.
The Telstar Pura Sterility Test Isolator complies fully with ISO 14644-7:2004
producing an EU GMP Grade A environment throughout the chamber.
4. Telstar Pura Sterility Test Isolator range:
Telstar’s Technical Sales Team will work with you to identify your exact requirements for your Sterility
Testing Isolator.
Telstar Pura 2
Single Chamber Isolator with
2 gloves.
Telstar Pura 3+
Double Chamber Isolator
(main chamber with 3 gloves + transfer chamber).
Telstar Pura 4+
Double Chamber Isolator
(main chamber with 4 gloves + transfer chamber).
Telstar Pura 3
Single Chamber Isolator with
3 gloves.
Telstar Pura 4
Single Chamber Isolator with
4 gloves.
Telstar Pura 2, 3 & 4 are for small scale sterility testing and choice of model is dependent on the number of tests to be
performed. These Isolators are designed for single batch sterility testing; the Isolators are pre-loaded with samples and test
materials before bio-decontamination. After bio-decontamination the batch is tested and then the Isolator is closed down at
the end of testing.
Telstar Pura 3+ & 4+ are used for continuous batch testing where large numbers of sterility tests need to be performed.
The Isolator is pre-loaded with the initial samples and test materials before bio-decontamination, after bio-decontamination the
sterility testing can proceed. Additional functionality with these Isolator models is that additional test materials and samples
can be introduced and bio-decontaminated via the transfer chamber whilst sterility testing is taking place in the main chamber.
The sterility testing process can then be continuous; transferring samples and test materials into the Isolator without detriment
to the working environment.
5. Main advantages of using an Isolator for Sterility Testing
• No requirement for a cleanroom environment surrounding the Isolator
• Reduced cost by not having to maintain and operate surrounding cleanroom
• Reduced operating cost with no gowning requirements for technicians,
cleaning, sterilising and time to gown and de-gown
• Removal of the main cause of contamination (operators) from the testing area
• Significant reduction in the risk of false-positive results and the corresponding
savings for investigations and product release delays
• Increased capacity for sample analysis
• Enhancement of compliance with domestic and international guidelines
and expectations
• Portability (Sterility Test Isolators can be relocated easily)
Key features and benefits:
• Positive pressure with alarm set points to avoid any product contamination.
• Single pass turbulent flow (EU GMP grade A) to maintain sterile conditions
inside the Isolator.
• The glass vision panels are ‘gull wing’ type which hinge upwards and
outwards. In the open position the doors are held open with gas struts.
• Inflatable seal technology on all doors assures very low leakage rate in
compliance with the most stringent leakage criteria stated in ISO 14644-7.
• High resistance to H202 without giving rise to excessive out gassing and
thus minimising bio-decontamination cycle time.
• Design suitable for bio-decontamination using a broad range of systems to
fulfil user requirements.
• Integrated or stand alone bio-decontamination system or unique Telstar
ionHP® system.
• PLC based user friendly automated control with automatic leak test function
(pressure hold test).
As standard the units include:
• Internal temperature humidity monitoring sensors.
• Oval shaped gloveports designed for sound ergonomic posture whilst
maximizing operator arm movement.
• Gloves are a three part design which enables changing of a glove without
compromising Isolator sterility.
• Grade AISI 316L stainless steel, fully welded, crevice free with smooth
internal surfaces guarantees complete cleanability.
• Support frame manufactured from AISI 304L stainless steel.
• Lighting fixtures within each chamber with external access for maintenance.
6. Options available for the Telstar Pura Sterility Test Isolator range:
Factory Fitted Options
• Bio-decontamination System
• Sterility Test Pump
• Glove Tester
• Paperless Chart Recorder
• Automated raise/lower Support Frame
• H202 external Monitoring Sensor
• Alternative types of Transfer Ports
• Internal Shelving Racking
Ancillary Options
• Non Viable Monitoring
• Viable Monitoring
• Continuous liner Grommet for Gamma
Irradiated liners or bags
• Continuous Liner bag welder
• Bag Welder mobile trolley
The production site where the products are made has been assessed
and given ISO 9001:2008 approval
All equipment is manufactured to allow it to be CE marked in
accordance with 98/37/EC Machinery Directive.
TELSTAR Life Sciences UK Ltd.
Unit 4, Shaw Cross Business Park
Dewsbury, West Yorkshire
WF12 7RF (UK)
T. + 44 (0) 1924 455 339
www.telstar-lifesciences.com
TELSTAR Life Sciences
Headquarters
Av/ Font i Sagué, 55
Parc Científic
Tecnològic Orbital 40
08227 Terrassa (Spain)
T. +34 937 361 600
F. +34 937 859 342
TELSTAR North America Inc.
1504 Grundy’s Lane
Bristol, PA 19007 (USA)
T. +1 215 826 0770
F. +1 215 826 0222
Fully Compliant
Telstar Pura Sterility Test Isolators are guaranteed to comply with
relevant standards and demands set by the regulatory bodies to
ensure conformance and client’s satisfaction, including:
• FS 209E Airborne Particulate Cleanliness
• cGMP Guidelines (current Good Manufacturing Practices)
• ISPE Guidelines (The Society of Pharmaceutical and Medical
Device Professionals)
• FDA (Food and Drug Administration)
• MCA (Medical Control Agency)
• American Glovebox Society Guidelines
Telstar provides a comprehensive validation service to clients
providing FAT/SAT/DQ/IQ/OQ PQ protocols if required.
Additionally Telstar UK has a dedicated Customer Service
division who offer a complete package to ensure your equipment
is working correctly and efficiently at all times.