Pharmaceutical Isolators and Containment Isolation, Rigid Barrier Isolators
At Shree Bhagwati Machtech (India) Pvt. Ltd, we offer Containment isolator, Isolator for Sampling & Dispensing, Granulation & Drying, Milling & Blending, Tablet Compression, Tablet Coating in Isolator, Capsulation, IPQC Isolators, API isolators and Granulation Isolator. The isolator manufactured by us, surrounds a two unit chamber with weigh balance, RMG, FBD/P, mill & blender with a pass box chamber, rapid transfer port, 2 gull wing doors and a wash-in-place system. They effectively function at a negative pressure and supports 20 air changes per hour & amp. Because of their high tech features, they can detect a containment breach, rings an alarm and gives ‘in rush’ protection.
These high-tech machines have tested designs and they are GMP compliant. These machines have a high demand in the market for mixing, granulating, milling and tableting because of their superior performance. We offer Granulation Isolator in 2 Kg and 10 Kg batch sizes. They are specially fabricated to provide containment OEL to 0.1 µgm/m3) for the effective processing of potent products and provide desired granulation results.
Containment Isolators are specially designed for creating controlled negative pressure environment. It also has an ability to effectively control & monitor operating parameters and safeguard the operator & the surroundings from the highly potent products. The the complete understanding of the process is required for successfully designing and manufacturing the production scale containment systems.
- Half Suit Isolators
- Sampling & Dispensing Isolators
- Charging & Off-loading Isolator
Containment is one of the most critical parts of any pharmaceutical process and a clear understanding of the process is utmost important for successful manufacturing. Additionally, it is very important to be able to provide a fully integrated system with third party equipment. Shree Bhagwati Machtech India Private limited excels in providing complete systems with third party equipment manufacturers. We have developed standard integration designs and techniques. Our previous integrated packages include: Blending, Milling, Sieving, Tabletting, Capsule filling, Freeze drying, Filling machines.
It is designed to protect the operator from airbone particles and potent APIs. It comes with and without integrated process equipment and it is used in various applications such as Dispensing/Weighing/Sampling, Sieving/Blending , Charging/API Addition, Mixing/Granulation, Formulation, Centrifuge, Freeze/Filter Dryer Off-Load/Pack-Off, Milling/Micronising, Tabletting, Final Packing/Blister Pack Isolators for API’s and cytotoxic compounds.
SHREE BHAGWATI Machtech India Private Limited has immense expertise in consultancy, design, procurement, installation and validation of customized containment solutions, fill finish/ aseptic filling isolators and dispensing and sampling to cater to stringent regulatory requirements of pharmaceutical and biotech industry.
Isolator is a physical barrier between the process and its operator. An isolator is a closed system, which can vary in size and features based on the intended application. Any manual or automatic operation can be carried out within this controlled environment, at particle or microbiological levels. The successful implementation of an isolation system depends on some important factors like control system, quality of air and type of gases used inside the isolator.
At, SHREE BHAGWATI Machtech India Private Limited, we offer complete end to end solution for concept building, proof of concept, containment testing and OEL (Operator Exposure Level, up to nanogram level) validation with operator training and maintenance.
Flexible Containment Technology is an industry proven latest technology of containment solution for maintaining OEL level (up to level 5). Flexible Containment Technologies include flexible enclosures suitable for almost every process. The usage of the film and integral gloves & sleeves supports various operations from filter dryer discharge and heel removal to tray dryer loading and unloading.
- Weighing & Dispensing Flexible Isolator
- Wet Granulation Flexible Isolator
- Belding Flexible Isolator
- Milling Flexible Isolator
- Fluid Bed Dryer Flexible Isolator
- Tablet Press Flexible Isolator
- Blistering Flexible Isolator
As a result of various technological development like transfer, filtration, granulation, and ventilation systems,Isolation technology has shown tremendous potential.
Isolator Applications Requirements for Containment Processing
- Mostly operated under negative pressure to provide maximum operator safety
- Usage of Negative pressure isolator for powder handling process and highly dispersal products
- Well designed motor and blower capacity as per the airflow requirement
- They must prevent air exchange with the surrounding environment (except through a HEPA filter)
- Equipped with nitrogen supply, if needed
- Negative pressure of -100 Pa
- Pneumatically controlled interlocked isolator door after the start of operation
- Visual display shows permanent status of the isolator
- Radii equipped isolator chamber > 15 mm
- Tightness test before every process
- “Push –push” system for exhaust air filters
- Integrated Rapid Transfer Ports (RTP) for loading and discharging, without affecting the surrounding environment
- Usage of Negative isolator for various processes like Sampling, Quality checking, Dispensing, Filtration, Product charging, Milling, Drying, Sieving, Blending, Solution Preparation, Weighing and R&D
API and Bulk Drug Isolators, Reactor Isolators, Formulation Barrier Isolators, Vessel Charging Isolators, Packoff Barrier Isolators, ANFD Discharge Isolators, Microniser Isolators, Bottle Filling Isolators, Sterility Test Isolators, Capsule Filling Isolators, Sampling Isolators, Centrifuge Isolators, Dispensing Isolators, Multi Milling Isolators, Jet Milling Isolators, Vacuum Tray Dryer Isolators, Containment Systems, Glove Boxes, Weighing Systems, Positive Pressure Isolators, Flexible Barrier Isolators, and Negative Pressure Isolators.