Sampling & Dispensing Isolator – Pharmaceutical Isolator
Sampling & Dispensing Isolator is to provide the highest level of operator protection during Sampling and Dispensing activities of powder. The Products to be handled are designed with an OEL level of 1-10 micrograms/m3 for 8 Hours. The containment equipment is working under Negative Pressure and the operation of the Isolator shall not create a static dust layer that cloud becomes airborne elsewhere in the facility. The Isolator is provided a Grade “D” environment within the working area.
- Negative pressure Isolator with dedicated air extraction system
- Turbulent airflow pattern within the work zone
- Grade “D” (Class-8) air classification attained prior to product exposure inside the chamber
- All filters are continuously monitored by differential pressure gauges
- All filters are safe changeable, to avoid cross-contamination of product and operator
- Chambers made of SS 316L to provide high chemical resistance
- Catch pot for collection of washed water
- Gullwing type toughened glass door in front and rear of the chamber with safety locks
- All doors will be locked during the operation mode. Only the pass box front can be allowed to transfer the product in it. All doors position are monitoring by sensors.
- FDA approved food-grade seal and gaskets
Technical Specification
ISO 14644-1: class ISO 5 (Class 100, Grade A)
Containment breach alarm
Low pressure and high pressure alarm
Filter choked alarm
Interlocked door system
HEPA Filters
OEL Categories OEL 1-5 (see Table)
Light Vacuum (100 Pa) system
Transfer System designs to suit application (optional)
Manual drum tippers (Automatic optional)
API Isolators Types
Isolator designs vary depending on the application/duty. Typical Schematic solutions for API and Bulk Drug Isolator applications include;
- Dispensing & Sampling Isolators
- Reactor Charging Isolator
- ANFD Discharge Isolator
- Centrifuge & Distillation Isolators
- Filtration & Drying Isolators
Formulation Isolator Types
Applepack supply custom designed Isolators for each specific application/duty. Typical Applepack solutions for Formulation applications include;
- Granulation Isolator
- QC Isolator
- Milling & Blending Isolator
- Pack off Isolator
- Sieving & Weighing Isolators
Design Features
- Rugged 316 Stainless Steel build with fully welded, large radius and polished corners
- Push-push type safe changeable HEPA filters on inlet and outlet vents
- cGAMP – PLC/HMI controlled – Digital pressure controller or Electrical controller to maintain a constant pressure
- Integrated Clean In Place / washable to reach every corner of chamber
- Integrated Weighing Scale, Nutsche Filter, Vacuum Tray Dryer, Continuous liner port and Drum loader
- Laminar airflow
- Oxygen monitoring / Nitrogen inertization
- Complete Documentation – FDS, DQ, FAT, IQ, OQ, OMM, Leak test, Lux, Noise, Air change, Filter integrity, Glove test and OEL
- Integration with RTP for safe and rapid transfer
- Split Butterfly valve for safe transfer of material
- Multiple or Single Chambers
- Isolator raise/lower systems for operator comfort
Rigid Barrier Isolators (-ve Pressure) from Shree Bhagwati Group. It seems like these isolators are highly specialized systems designed to ensure operator safety while handling hazardous, toxic, or potent substances in various industries, particularly pharmaceuticals, chemical, and food sectors.
Here’s a breakdown of key points from your description:
Key Features of Rigid Barrier Isolators (-ve Pressure):
- Negative Pressure Operation: These isolators maintain a light vacuum (100 Pa), ensuring a safe, risk-free environment for operators when handling hazardous materials. The vacuum helps prevent toxic or potent vapors from escaping into the surrounding area.
- Applications:
- API (Active Pharmaceutical Ingredients):
- Dispensing & Sampling Isolators
- Reactor Charging Isolators
- ANFD Discharge Isolators
- Centrifuge & Distillation Isolators
- Filtration & Drying Isolators
- Formulation:
- Granulation Isolators
- QC Isolators
- Milling & Blending Isolators
- Pack-off Isolators
- Sieving & Weighing Isolators
- API (Active Pharmaceutical Ingredients):
- Design Features:
- Constructed from 316 Stainless Steel, ensuring durability and resistance to corrosion.
- Safe-change HEPA filters for effective filtration at both the inlet and outlet.
- cGAMP Compliance: PLC/HMI controlled, digital pressure controllers, and full system documentation, including FAT, IQ, OQ, and OMM.
- Clean In Place (CIP) for thorough cleaning of the isolator’s interior.
- Inertization (Oxygen Monitoring) and Laminar Airflow for controlled environments.
- Integration with Rapid Transfer Ports (RTP) for safe transfer of materials.
- Safety Features:
- Interlocked air-locks, doors, and visors for maximum operator protection.
- Alarms for breach detection, low/high pressure, and filter clogging.
- Light vacuum system (100 Pa) for maintaining negative pressure.
Applications in Various Industries:
- Pharmaceuticals: Handling cytotoxic drugs, oncology drugs, micronizing, milling, sieving, and aseptic processes.
- Chemical: Pilot plant operations, toxic agrochemical applications, fluid bed dryers.
- Other Industries: Electronics manufacturing, food R&D labs, and beverage processing.
Technical Specifications:
- ISO Class 5 (Class 100, Grade A) cleanroom standard.
- OEL Categories: OEL 1-5 for different levels of containment.
- Transfer Systems: Optional manual or automatic drum tippers, split butterfly valves for material transfer.
These isolators seem ideal for a wide range of industries where safety, clean environments, and precision handling of hazardous materials are paramount.
If you’re looking for more specific details or want to proceed with an inquiry or purchase, it might be useful to get in touch directly with Shree Bhagwati Group for tailored solutions based on your particular application and requirements.