Schematic Engineering Industries

Plot NO 18/A,Phase-I, Road No 10,SVCIE, Jeedimetla,Hyderabad-500055,Telangana, India

Rigid Barrier Isolators (-ve Pressure)

Rigid Barrier Isolators (-ve Pressure)

Schematic Industries are specialists at manufacturing bespoke, client specific Barrier Isolator systems to cGMP and cGAMP standards. We manufacture both Rigid and Flexible barrier isolator systems with a negative pressurised internal environment and Rigid isolators with positive pressurised internal environments.

Our negative (-ve) barrier isolators are essential where the process media is hazardous, dangerous or has an unacceptably high toxic level.

These barrier isolator systems operate under a light vacuum (100 Pa) to provide an uncompromising and continuous isolation of the interior from the external environment. This also provides a risk-free environment for the operator as potent vapours are taken to the systems filtered exhaust rather towards to operator.

Typical barrier isolator types/applications in both API and Formulation sectors are shown below, together with the design features and technicial attributes of Schematic's Rigid Barrier Isolator solutions.

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

Schematic supply custom designed Isolators for each specific application/duty. Typical Schematic 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

Operational Benefits

Stable and accurate results
Clear visibility during operation and cleaning
Operator safety - fully interlocked air-locks, doors and visors
Uncontaminated process media
cGAMP - Alarms and safety measures in case of breach

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)

Chemical Industry Applications

Pilot plant and laboratory equipment
Toxic Argochemical applications
Filter Dryers and Fluid Bed Dryers (FBD's)

Pharmaceutical Industry Applications

Micronizers, Multi-milling, Pulverising, Jet milling, Sieving and Weighing
Handling Cytotoxic drugs
Oncology drugs and Pack-off
Aseptic and Asepsis processes
Tablet presses and coaters

Other Industry Sectors

Electronics Manufacturing
Beverage / Juice processing
Food Research & Development labs
Dispensing and Sampling
Roll Compactors

Technical Specs

Rigid Barrier Isolators (+ve Pressure)

Rigid Barrier Isolators (+ve Pressure)

Schematic Industries are specialists at manufacturing bespoke, client specific Barrier Isolator systems to cGMP and cGAMP standards. We manufacture both Rigid and Flexible Isolator systems with negative pressurised internal environments and Rigid Isolators with positive pressurised internal environments.

Our positive (+ve) barrier isolators are essential where possible external contamination from the clean-room environment or personnel can not be allowed to enter the process media.

These positive isolators are generally more complex than our negative range and controlled by PLC or HMI control panel. During automatic operation, the barrier isolator goes through its start-up sequence ensuring all checks are completed. It then conducts a decontamination operation by VHP and once successfully performed it auto switches to show an 'isolator healthy' operation ready for processing.

These systems are commonly used for Sterility applications in the pharmaceutical sector, as discussed below.

Design Features

Rugged 316 Stainless Steel build with fully welded, large radius and polished corners
Flat type safe changeable HEPA filters on inlet and outlet vents (push-push filters are optional)
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 and Continuous liner port
CG screen to ensure 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
Multiple or Single Chambers
Separate air handling unit for main chamber and pass box
Isolator raise/lower systems for operator comfort
Disinfection or decontamination by VHP ( Vapourised Hydrogen Peroxide) cycle. Designed with rapid release of VHP after decontamination
Record and retrieve the isolator operation data.
Multilevel password protection for Isolator operation, maintenance and control
Minimum air changes 10
Excellent lux operator lighting conditions.