Safe and contamination-free dosing, sampling, (re-)filling and weighing of small quantities of highly active or hazardous substances is only a small choice of customer specific operations that can be performed with HECHT's Single-Use Isolator (EWI). The EWI is a flexible, completely closed foil system operatable with gloves. It guarantees operator and product protection due to the use of a flexible foil and different customized connection adapters for various kinds of bins (drums, sacks, cartons, etc.) There is no need for a time-consuming cleaning or cleaning validation.
Depending on the use case, the number of ports for loading and unloading, the connection of the gloves for the operation of dryers, blenders, granulators etc. will be determined according to your customized needs.
One special option for the EWI is our patented weighing system. The active weighing technology is located outside of the isolator so there is no danger of contamination. Only the scale pan is mounted in the inside. It is possible to weigh in different bulk solids to a minimum weight of 2 grams.
Safety
- Primary Containment due to protective foil
- Safe (re)filling and weighing in of small quantities
- Operator and product protection due to negative and positive pressure
- Leakage test for every foil isolator
- High Containment-OEL: up to 1µg/m³ (OEB5) - within the laminar flow cabine: up to 200 ng/m³(OEB6)
- No cross-contamination
Cost Efficiency
- Low investment and maintenance costs
- Hardly and costs for cleaning and validation
- Short changeover time
Flexibility
- Adaptable to different kinds of bins and applications
- Process control can be adapted to OEL-requirements
- Inertisation (optional)
- Mobile and location-independent
- Quick product change due to single-use technology, short setup times
- Different bins with liners useable
- Various foil isolators within one frame individually designable
- System consists of a permanent fixed element and a flexible part
- Permanent part: stainless steel frame with working surface, dedusting unit, and intake for single-use isolator
- Control unit is customized based on OEL requirements, can operate in underpressure mode with or without inertization
- EWI can handle different processes with various ports for customized manipulations (e.g. magnetic stirrers, weighing systems, power and air feedthroughs)
- Multiple loading/unloading ports and gloves can be integrated based on process needs
- Built in GMP-compliant design
- Flexible part: single-use foil isolator (PE, PU, conductive) mounted quickly to the permanent frame
- Various designs and combinations of single-use isolator systems are possible
- Product-contact surfaces comply with pharma and food industry requirements
- Product handling takes place inside the isolator using gloves
- Single-use foil is mounted, interfaces connected, and system stabilized with pneumatic seals or vacuum plates
- Product bins are connected to the inlet port or directly inserted into the isolator
- Outer liner is fixed to the connecting port with pneumatic seal, and product handling begins
- Operator uses gloves to open inner liner and handle the product, with both isolator and bins remaining fully closed
- After process completion, bins are removed using double tie-off and cut-off method, keeping everything sealed
- Foil isolator is removed after deactivating the pneumatic seal, and a new cycle can begin immediately
- After handling, the isolator is disposed of without the need for cleaning or decontamination
- EWI is ideal for handling small bins or processes requiring 2 liners
- Flexible, mobile station that only requires 230V power and compressed air supply
