Capsule filling machines and tablet presses are expensive long term investments. The conundrum for manufacturing is how to address greater 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.
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.
Project implementation approach
From drawings and discussions on user requirements, a budget cost and definition is formed. PSL considers some of the following:
- Is the feed system contained and what are the alternatives?
- Is the de-dusting product collection system contained and what methods could be used if required?
- How to access the machine safely and operate in a contained manner?
- Do we need to utilise a contained internal vacuum cleaning system?
Front end design study
We need direct access to the installed machine to undertake accurate site measurements as the design detail will be based on these measurements. This provides an opportunity for additional discussions and agreements and to produce final costs for the project implementation.
Project implementation
A full documentation package is provided for review prior to commencing final manufacture. The ideal situation is to ship the machine to our key service centre for final assembly and testing. Alternatively, it is possible to install on-site, however this does require larger costs and greater time.
Documentation packages and services up to IQ/OQ would normally be included.
The image on the right is an example of our latest retrofit containment project on 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.
Our client required less than 1ųg /m³ Operator Exposure Level (OEL) and required us to retrofit containment onto an existing capsule filling machine. Since PSL has experience of this type of application on numerous existing systems, we did a feasibility and mock-up study on their Bosch 400.
We 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.
Manesty tablet press with contained de-dusting
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 isolator (pictured below left). This comprises Capsugel’s Xcelodose precision powder microdosing system, integrated with PSL’s isolator for operator protection from exposure when filling potent compounds.
PSL has been working with Capsugel on the Xceloprotect isolator
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 while 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.
