Overview

Flexible Isolator

The flexible isolator redefines containment solutions by combining high‑strength engineered polymer films with accurate airflow control. It forms a sealed, ergonomic workspace that physically separates operators from critical materials.

Rapid to install, simple to modify, and compatible with single‑use consumables, it empowers your teams to accelerate your project timeline while maintaining safety and compliance.

Core Advantages

High Performance

Modern flexible films and fail‑safe pressure‑decay monitoring create a verified enclosure. The system simultaneously protects the product from external contamination.

Rapid Deployment

Compared with a rigid stainless steel isolator, a flexible isolator can be designed, fabricated, and deployed on-site within 4 to 8 weeks.

Low Cost

Flexible isolators require a fraction of the initial investment of rigid systems because they utilize disposable polymer films instead of costly welded stainless steel.

OEB5

Containment Level

4-8wks

Lead Time

-60%

Initial Investment

Decision Framework

Flexible Isolator vs. Rigid Isolator: Which Fits Your Process?

Evaluation Metric	Flexible Isolator	Rigid Isolator
Construction Material	Polymer film, lightweight	Stainless steel or acrylic hard shell
Containment Capability	OEB 4-5, <1 μg/m³ achievable	OEB 5-6, < 0.01 µg/m³ achievable
Relative Initial Cost	20% - 40%	100% (Baseline)
Installation & Footprint	Compact, portable, rapid deployment	Fixed, large footprint, complex installation
GMP / Pharma Suitability	GMP-compliant, single-use film options	Full GMP compliance, validated CIP/SIP
Lead Time to Deployment	4 - 8 weeks	32 - 50+ weeks
Batch Turnaround / Swapping	1 - 2 hours (Single-use swap)	24 - 72 hours (Requires CIP/VHP)
Cleaning Validation Cost	$0 (Disposable)	High (Continuous testing)

* Containment performance data based on surrogate powder testing per SMEPAC guidelines. Actual values vary by process integration.

Solutions

From standalone lab-scale enclosures to fully integrated bulk handling equipment.

Drum Transfer Isolator

The drum transfer station is designed specifically for safe raw material dispensing, and mass transfer from bulk drum containers. The entire assembly is mobile and can be wheeled over the piece of process equipment to be charged.

HPAPI Flexible Isolator

A high-containment, single-use glovebox engineered to handle Highly Potent Active Pharmaceutical Ingredients (HPAPIs) requiring OEB 4 and OEB 5 compliance.

Benchtop Isolator

A compact, space-saving flexible isolator designed to sit or stand directly on standard laboratory workbenches or tables. It is suitable for lab-scale R&D and small-batch weighing.

Flexible Enclosure

Made from flexible film materials, it is a custom-engineered barrier system designed to create a controlled, enclosed workspace for protecting the product, the operator, or the surrounding environment.

Drum Tipper

A mechanical handling device used to lift, tilt, and empty drums or barrels safely and efficiently. It helps reduce manual handling, improve operator safety.

Continuous Liner

A continuous, tubular polymer film system utilized for the safe bag-out and disposal of contaminated products, waste etc. A continuous liner helps maintain containment, reduce operator exposure, prevent cross-contamination.

Features

Effective Containment

Despite being lightweight and flexible, these systems deliver great protection that is just as effective as that of a rigid isolator.

Customizable Design

Can be designed with glove ports, sleeves, transfer ports, pass-through chambers, continuous liners, HEPA filtration, or integration with process equipment.

Flexible Film Construction

Made from transparent flexible film such as TPU, PE, PVC or other polymer films, offering good visibility and operational flexibility.

Compact & Space-Efficient

Lightweight and easy to install, move, or retool, making it ideal for limited lab or production spaces and for temporary containment setups.

Process Ergonomics

The flexible film naturally moves and conforms to the operator's hands. The good visibility of modern films ensures an unobstructed view of intricate tasks.

Easy Cleaning

Smooth, non-porous film surfaces are easy to wipe down, decontaminate. It can be replaced without major downtime -- no need for complicated disassembly.

Specification

All parameters are verified under factory acceptance test (FAT) conditions. Custom configurations available upon process audit.

Containment & Environment

ISO Cleanliness Class	ISO Class 5 (Grade A)
Containment Performance	< 1 μg/m³ OEL
Pressure Differential	−35 to −80 Pa (neg. mode)
HEPA Filtration	H14 (EN 1822), 99.995%
Bio-decontamination	VHP / Manual Disinfection

Structural & Materials

Frame Material	316L Stainless Steel
Flexible Film	LDPE / TPU / PVC
Glove Port Standard	ISO 11933-2
Surface Finish (Ra)	≤ 0.4 μm (interior)
Transfer System	Rapid Transfer Port

FAQ

Answers to the most common technical and commercial questions from procurement managers and process engineers evaluating flexible isolators.

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Is a Flexible Isolator typically operated under positive or negative pressure?

It depends.

For handling potent, toxic powders, the isolator is usually operated under negative pressure (e.g., -35 Pa to -70 Pa) to prevent leakage of contaminants into the environment. For protecting product sterility (when the material is non‑hazardous), positive pressure may be used to keep outside contaminants out.

How to verify the leak-tightness and structural integrity of a flexible isolator before production?

Visual inspection (overall appearance, gloves, O-rings) → Glove integrity test → Pressure decay test (overall leak-tightness) → Alarm and interlock test → Record and archive

How are materials transferred into and out of a Flexible Isolator?

Common transfer methods:

RTP (Rapid Transfer Port) – A high-containment, bidirectional transfer mechanism.
Continuous liner system – For waste or high‑activity powder removal; the liner is heat‑sealed and cut segment by segment.
Airlock / pass‑box – Rigid or flexible chamber with interlocked doors.
Zip closure – Quick opening for large items or maintenance; double zip or gas‑tight zipper designs offer better containment.

Does a Flexible Isolator need to be equipped with an H14 HEPA filter?

Yes, for pharmaceutical, sterile, or high‑potency applications an H14 HEPA filter (≥99.995% efficiency per EN 1822) is typically required.

What are the key maintenance points for a Flexible Isolator?

Key maintenance points:

Film inspection – check for abrasion, cracking, yellowing.
Glove and glove port – replace gloves at scheduled intervals; verify port seals.
HEPA filters – monitor differential pressure; perform integrity testing annually.
Cleaning & disinfection – ensure disinfectants do not degrade the film or gloves.
Instrument calibration – calibrate pressure sensors, airflow meters, temperature probes, and alarms.