Search

Sampling & Dispensing Isolator – Pharmaceutical Isolator

Compare

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.

 

Features
  • 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
Back to Top

Stay Ahead in Industry: Subscribe for Exclusive Updates

You have successfully subscribed to the newsletter

There was an error while trying to send your request. Please try again.

Industrial Development will use the information you provide on this form to be in touch with you and to provide updates and marketing.