
API handling
Containment solutions for API handling
Safe, dust-free handling of highly active pharmaceutical ingredients (APIs/HPAPIs) to ensure personnel protection and product purity.
Pharmaceuticals
Containment
HPAPI
OEB
Overview
Highly active ingredients require closed systems
Professional API handling is crucial for safety in pharmaceutical production. In particular, when dealing with highly active pharmaceutical ingredients (HPAPIs), operators must be protected from exposure and products from cross-contamination. Open processes pose a considerable risk in this context. To meet the strict OEB requirements (Occupational Exposure Band) and ensure the highest level of safety, closed containment systems are essential. These systems enable dust-free handling of APIs and minimise the risks to people and materials, which is fundamental to GMP-compliant working.
The risks of API handling
Dust generation and particle exposure
Unprotected processes expose operators to harmful dusts and jeopardise compliance with occupational exposure limits (OEL).
Cross-contamination between batches
Product residues from earlier batches can contaminate subsequent batches and affect their quality and safety.
Compliance with OEB classifications
Achieving and maintaining containment levels up to OEB 6 containment requires specialised and validated systems that comply with regulatory requirements such as REACH.
OUR SOLUTIONS
Rhein-Plast containment packaging materials for APIs
Rhein-Plast offers flexible and efficient containment systems for API handling. Our solutions, such as continuous liners and transfer bags, are made from high-quality, GMP-compliant polyethylene films. They enable closed, dust-free transfer of powders and liquids and can be seamlessly integrated into existing filling and production processes. This approach ensures not only the protection of personnel, but also the integrity of the product. Our systems are designed for demanding HPAPI containment and support you in meeting the highest safety standards.
advantages
Ensuring product purity
Maximum personal protection
Effective protection of employees against highly active substances.
Ensuring product purity
Prevention of contamination through a closed process chain.
Protection against cross-contamination
Single-use systems prevent the transfer of active substances between different batches.
Seamless integration
Integration into isolators and cleanroom processes of ISO classes 5, 7 and 8 for maximum product purity and the highest process reliability.
Products
Suitable products for your API handling
Request a containment solution for your API process now
Speak with our containment experts about your individual requirements.








