Proven dust emission levels ≤0.08 µg/m³ significantly exceed OEB5 requirements.
Powder Transfer Bags: Contained Powder Handling up to OEB5
Rommelag FLEX Powder Transfer Bags are part of the Flecotec Material Transfer System (MTS). They enable contamination-free transfer of highly potent powders up to OEB5 and integrate as a secondary containment interface in existing processes. The result: maximum product safety, no cleaning re-validation, and a free cross-section without a "ring of concern".
Functionality
How the MTS works
The MTS is a thoughtfully engineered, single-use system of transfer bags and adapters for closed powder handling at OEB-5 level. At its core is our patented ZIP mechanism, which connects components to create a sealed transfer path. The MTS can be flexibly integrated as a secondary interface within your process while preventing direct product contact at the interface.
A slider connects our ZIP components and enables secure docking of the Powder Transfer Bags.
The ZIP mechanism is opened, enabling powder transfer under closed conditions.
Retracting the slider undocks the bags. The ZIP mechanism automatically reseals, ensuring a safe and error-free process.
Docking
A slider connects our ZIP components and enables secure docking of the Powder Transfer Bags.
Opening and connecting
The ZIP mechanism is opened, enabling powder transfer under closed conditions.
Closing and undocking
Retracting the slider undocks the bags. The ZIP mechanism automatically reseals, ensuring a safe and error-free process.
Advantages
Your Benefits at a Glance
Universal compatibility with all Flecotec components and adaptable interface sizes for versatile application scenarios.
Our flexible standard can be tailored to customer-specific needs to meet even the most demanding requirements.
The free cross-section eliminates the ring of concern, minimizing cross-contamination risk and validation complexity.
Optimized bag geometry and antistatic properties enable near-complete discharge, substantially reducing product losses for high-value APIs.
As a secondary interface created by the ZIP closures, your existing processes remain unchanged—typically eliminating the need for re-validation.
Specifications
Technical data
Containment performance
- Dust emission values: ≤1.0 µg/m³ (OEB5 standard)
- Validated performance in practice: ≤ 0.08 µg/m³ (SMEPAC)
- Overpressure resistance: max. +200 Pa (2 mbar)
FlecoZIP Powder Transfer Bags
- Volumes: 5, 10, 15, 20, 25 liters (others on request)
- Open-end bags available on request
- Material: FlecoFilm DL (double layer PE, antistatic)
- Nominal diameters: DN 100 mm (4"), 150 mm (6"), 200 mm (8")
- Reducing adapter: 6"/4", 6"/8" (stainless steel 1.4404)
MTS system components
- Transfer tube: Stainless steel 1.4404 or HDPE
- Transfer ring: HDPE with pharmaceutical approval
- Tri-clamp connections: PA (nylon) with FDA conformity
Material qualification
Our Powder Transfer Bags are produced from our in-house FlecoFILM DL. This double-layer PE film is antistatic and has been successfully tested according to:
- EU No. 10/2011 (Plastics Regulation for food contact)
- USP <661> (Plastic Materials of Construction)
- USP <87> (Biological reactivity, in-vitro cytotoxicity)
- USP <88> (Biological reactivity, in-vivo, Class VI)
Quality Assurance
Every shipment includes, as standard:
- Product certificate with batch documentation
- ISO 9001 certificate (quality management system)
- DIN ISO 15378 certificate (primary packaging for medicinal products)
- Optional: USP, EP, JP declarations of conformity