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
