Capsule filling machines and tablet presses are expensive long term investments. The conundrum for manufacturing is how to address increased safety requirements from ever increasing drug potency.
It is not normally viable to replace existing machines with new high containment versions, and sometimes a quicker solution is required if a new production demand needs to be considered.
Powder Systems Ltd (PSL) has resolved these needs over many years and is able to efficiently implement a retrofit system, which is bespoke designed to suit a specific model.
Latest high containment retrofit solution for capsule filling machine
PSL's latest retrofit containment project included a Bosch capsule filling machine which was completed for a US drug manufacturer.
The design includes the gloves being held in special gloveport retainers with integral safety interlocked guards.
PSL's client required less than 1øg /m³ Operator Exposure Level (OEL) and asked PSL to retrofit containment onto an existing capsule filling machine. Since PSL had experience of this type of application on numerous existing systems, they did a feasibility and mock-up study on their Bosch 400 unit.
PSL removed the existing doors and retrofitted new swing-out doors with safety interlocks. Close detail was paid to the operational and maintenance access of the machine.
High containment retrofit solution for tablet press
The above image is an example of a Manesty tablet press with contained de-dusting. This project was undertaken for a Swiss drug company in China.
Recently PSL has been working with Capsugel on the Xceloprotect(TM) isolator. This comprises Capsugel's Xcelodose® precision powder micro-dosing system, integrated with PSL's isolator for operator protection from exposure when filling potent compounds.
All mechanical and electrical mechanisms of the Xcelodose system are contained within the lower half of the isolator to avoid contamination and facilitate easy access without breaking containment.
Dispensing, sampling and milling
PSL has been providing high containment formulation solutions for 23 years. All systems can be nitrogen purged, achieving high containment to nanogram levels for the handling of highly potent APIs.
PSL's Dispensing Isolator can accommodate all types and sizes of pharmaceutical containers using an interlocked double inflatable seal system, which can incorporate PSL's tiltable multi-drum chamber. PSL has vast experience integrating transfer devices, clean-in-place (CIP) and weigh systems.
PSL's Milling Isolator provides high containment and a controlled safe environment whilst performing size reduction of active ingredients. It has been designed for enhanced operator viewing, ergonomics and an assured explosion protection system has been fully integrated into the design. PSL's nitrogen purge systems are able to achieve less than 1% oxygen.
PSL is an international manufacturer of filtration, drying and high containment solutions for small-scale production to full process systems. PSL provides advanced containment processes for highly potent and valuable products including sterile, oncology, hormone and many other pharmaceutical compounds.
PSL has offices and distributors worldwide to easily assist their global customer base.
Powder Systems Limited
+44 (0)151 448 7700
Powder Systems Ltd (PSL) provides a full range of filtration, drying and contained powder handling products to worldwide industry leaders including Pfizer, GSK and BMS. From small-scale production to full process systems PSL's isolation products provide containment to nanogram levels for handling highly potent APIs.
PSL provides a full service that includes: OEL testing, installation, operator training, aftercare, reliable spare parts and emergency call out to anywhere in the world. PSL has been established for 23 years and has offices and distributors worldwide to easily assist their global customer base.
PSL press contact:
Camille Flores - firstname.lastname@example.org - +44 (0)151 448 7700