Granulation Line Isolators, Isolator for Granulation line – Containment OEB 5, Granulation Line Isolators -Complete Granulation line consisting of Sifter, RMG, FBD, Cone mill and Blending fitted in a single isolator chamber thus complying to required OEL levels.
OEB4/5 High Containment
There are two types of Granulation Lines employed in the production of solid dosage forms in the Pharmaceutical Industry.
Complete granulation lines for small batch production, mounted under isolator in high containment OEB 5. A line can be composed by a high shear mixer, fluid bed dryer (12-bar pressure resistant construction), cone mill to calibrate dry or wet products, possible kit for the transfer of the powder by vacuum, a washing and drying system. All systems have been designed to ensure maximum operator protection, during handling operations of products with high level of toxicity.
As the Particle fineness of pharmaceutical ingredients increases, so increases its effectiveness & opens up the possibility for more efficacious drug delivery systems.
But with these benefits, also the handling of such fine particles gets stringent in complexity, especially if the content to be handled is Potent in nature.
Emissions of API into the environment have to be prevented, and exposure limits regarding occupational health must be considered (OEL – Occupational Exposure Levels). While keeping safety in mind, the product itself also needs processing to be in its final form.
This processing call’s for a variety of equipment’s based on the properties. Considering granulation itself, it may require, Rapid Mixer Granulator, Fluidized Bed Dryer & Further Line Equipment.
As the product is potent, one of the methods to arrest emission of these hazardous API’s is handling the process equipment inside a closed chamber with an active ventilation system, i.e. an Isolator to term.
If the batch size is smaller in parallel, it makes the Process Equipment’s footprint smaller, and this equipment can be installed inside an Isolator, further ensuring the operator safety.
For such Isolators, Process Chambers must be designed for a rigorous ventilation system & avoidance of dead areas and non-accessible zones. Gaps, Sharp Edges, Holes, and Welds have to be avoided as far as possible. The inner radius of the base plate to the wall should be at least 15 mm ± 3 mm radius to avoid any material getting accumulated at corners & also to facilitate easy cleaning. Mono-bloc design and minimization of the number of parts would aid to a better design.
Isolators and Their Use in Sterile Manufacturing
High Containment Wet Type Granulation Line Manufacturers, Suppliers
It is suitable for the production of highly toxic, highly active, and highly allergenic solid drugs, and must reach containment OEB4 & OEB5 to minimize the hazards of the operators during the production process and the impact on the environment.
1.Adopt air bag seal,safety interlock control;
2.Adopt PE bag or ab valve for loading and unloading;
3.Adopt BIBO system for air exhaust, with F9/H13 filters;
4.WIP cleaning/CIP cleaning/Manual disassembly cleaning.
OEB 4/5 High Containment Sampling Isolator Series
Multipack’s Dispensing & sampling Isolator is designed to handle OEB 5 compounds. Its unique and efficient make provides high containment levels.
We strive to provide a safe and sound working environment to our employees and customers. Therefore, our team of experts have designed a wide range of high containment devices and equipment.
During the past couple of years, cleaning measures have become more difficult due to rapid progress in the pharmaceutical industry. With the Shree Bhagwati dispensing technology, the uniquely designed isolator surfaces meet the overall cleaning needs while making it easy and convenient.
A negative pressure isolator is a machine which isolates the worker from the processing units of OEB 5 compounds with the help of a physical barrier. Its physical isolating barriers include contained chambers, operating gloves, continuous liners, RTP valves, A/B valves, etc. The air inlet and exhaust of the negative pressure chamber make their way through the high-efficiency filter to prevent the cross-contamination of the material and the environment.
Our multipurpose isolator series will provide you with multiple economic benefits. They have lower costs and reduce the risks of cross-contamination over traditional hard wall isolators.
OEB 4/5 High Containment Sampling Isolator: Technical Parameters
Power | 220v 50HZ |
Chamber Material | SU316L stainless steel |
Power Load During Negative Pressure Maintained Period | 1000w Turbulence |
Type Of Airflow | -80pa~一50pa |
Air Change Rate | More than 20 times per hour |
Contained Grade | OEB5 |
Noise Level during Negative Pressure Maintained period | W65dB ( A ) |
Chamber Contained Standard | Meet the requirements of ISO10648-2 standard |
OSD ISOLATORS
Dispensing/ Weighing Isolator
IPQC Isolator
INJECTABLE ISOLATORS
Sampling and Dispenser Isolators are perfect for better containment of OEB 5 compounds and production quality in pharmaceutical manufacturing processes. For customers in search of suitable quality isolators, Shree Bhagwati is the best equipment partner.
With our years of industry experience, we are equipped with the best technology and staff to ensure all the testing, sales, repair, and servicing requirements. Our team has the skills, knowledge, and tools to comply with all the OEB 5 compounds requirements.
Solid dosage production line: Pre-treatment, High shear mixer, Roller compactor, FBD, Blender, Tablet press machine, Coater, Capsule filling machine, counting line, Washing machine, etc; -OEB4/5.
Containment Isolator, Granulation line, Tablet press machine, Coater, Capsule filling machine, Packing line, etc. -Packing line: Blister packing machine, Cartoning machine, etc. -API system: filtration, crystallization, drying.,
Extraction line: Extraction & concentration series, Storage & dispensing series, etc.
Water system: Purified water generator, Multiple effect water still, Pure steam generator, Storage & distribution system, Process preparation system, biological preparation system, etc.; -Intelligent warehousing/sorting/formulation/ feeding system
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Specialists at manufacturing bespoke, client specific Barrier Isolator systems to cGMP and cGAMP standards. We manufacture both Rigid and Flexible barrier isolator systems and a variety of workstation process equipment.
Supplied with zip door entry with multiple glove ports our flexible barrier isolator solutions are ideal for small scale weighing and dispensing operations, handling highly potent API’s.
Automatic Aseptic Filling Line Isolator equipped with world-class filling line for vial, ampoule, prefill syringe isolator provides complete isolation in critical operations such as aseptic filling and closing machine attache with special liquid transfer technology for continuous and aseptic filling and Real time monitoring the velocity, differential pressure, humidity, temperature with Complete validation protocols to comply with FDA, EMA, GMP, 21CFR Part 11 , FAT.
Sterility Test Isolators – Sterility Test Barrier Isolators requirements including Half suits, six glove ports, Multiple chamber construction and custom sizes. Sterility Testing is therefore an essential element of sterilization validation and barrier isolators are employed to help eliminate risk and protect the product from both the process and externally generated factors.
We export high quality Granulation Line Isolators, Isolator for Granulation line – Containment OEB 5 to Afghanistan, Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, The Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burma, Burundi, Cambodia, Cameroon, Canada, Cabo Verde, Central African Republic, Chad, Chile, China, Colombia, Comoros, Congo, Democratic Republic of the Congo, Republic of the Costa Rica, Cote d'Ivoire, Croatia, , Curacao, Cyprus, Czechia, Denmark, Djibouti, Dominica, Dominican Republic, East Timor (see Timor-Leste), Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Ethiopia, Fiji, Finland, Gabon, Gambia, The Georgia, Germany, Ghana, Greece, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Holy See, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, , Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kiribati, Korea, , South Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macau, Macedonia, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Mauritania, Mauritius, Mexico, Micronesia, Moldova, Monaco, Mongolia, Montenegro, Morocco, Mozambique, Namibia, Nauru, Nepal, Netherlands, New Zealand, Nicaragua, Niger, Nigeria, , Norway, Oman, Pakistan, Palau, Palestinian Territories, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Sint Maarten, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Korea, South, Spain, Sri Lanka, , Suriname, Swaziland, Sweden, Switzerland, , Taiwan, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vanuatu, Venezuela, Vietnam, Yemen, Zambia, Zimbabwe, and more. at lowest price.
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