The clients overall project aim was to achieve homogenization (blending/tumbling) of potent lyophilised polypeptide product offloaded from a separate isolator and to be able to then sub divide into containers within a new isolator. The final step would be to heat seal each container via continuous liner ready for final packaging and transportation to their numerous big pharma clients around the world.
What is a Peptide/Polypeptide and what is its purpose?
· Some pharmaceutical products use peptides and polypeptides in vaccines to stimulate antibody production.
· Biochemists generally use the term polypeptide to describe medium-size peptide chains consisting of 10 or more amino acids. The pancreatic hormone insulin is a widely known example of a polypeptide. Insulin helps your body to use and store sugar.
Newly achieved process overview:
From a separate lyophilising isolator, a high containment 60L bag sourced from Rommelag –FLEX, one of the four divisions of Rommelag who are specialists in plastic films for the pharmaceutical industry and flexible containment solutions, is charged with freeze dried peptide product. It is then transported to the facility’s newly supplied Pharmatech powder blender/homogeniser – which has also been designed to suit OEB 6 charging and offloading from the containment bag into a special stainless steel blending vessel, and then subsequent washing of the blending vessel.
After the product has been homogenized and the bag is charged, it is transported to the Extract Technology Isolator for the purposes of offloading the product via a rotary valve for metering the product into jars. Finally the product is heat sealed via a continuous liner port on the exit airlock, for the purposes of final shipment to Polypeptides customers. Note a final packaging step is completed after the heat sealing, outside of the isolator.
Specific process details within the Extract Technology isolator:
Via the Onboard isolator HMI, the bag cradle mechanism located in the upper section of the isolator is lowered (operator raise/lower platform by client). The upper chamber door is opened and the bag is placed within. The operator then closes and seals the bag access door. Via the on Board HMI, the bag is then raised – via a foot switch pedal- to its set-point (in close situ to the rotary valve inlet connection) so that the bag outlet connection is in close proximity to the rotary valve for connection. The main chamber door is then opened and the client attaches the bag to the valve. The door is closed, and the isolator production mode negative pressure environment is achieved. Empty jars are brought into the main chamber via the entry airlock and then placed in their dedicated position, on a scale below the rotary valve with an indicator located on the isolator back wall. Only when the jar is in place can the 2 safety buttons (that allow operation of the rotary valve) activate. The Rommelag-FLEX containment bag special zip interface (FlecoZip) technology is opened allowing product to flow to the rotary valve and for product to be dispensed into the jar below. The jars are then manually closed and then moved from the main chamber into an exit airlock for temporary storage. The exit airlock also houses a bag out port door as the bags are further sealed by a continuous liner via an Extract Technology supplied heat sealer.
Additionally, each chamber houses CIP sprayballs & wash guns with fully configurable recipes via the HMI allowing for automated or manual wash cycles. Note all inlet/outlet drains are automated with control communication to the clients dosing system.
The project brought about great collaboration not just with our client but with other suppliers contracted by Polypeptide and allowed for creating new effective solutions. The successful commissioning of this project to the clients satisfaction is a testament to Extract Technology’s ability to turnkey bespoke projects.
Upon launch of the project the team internally dictated a number of critical success factors for our new isolator:
· Design to enable ergonomical dispensing of API ranging from milligram to kilogram scale of operation
· Multi-product use, enable automatic CIP with Purified Water and minimize drying times.
By end of year 2015 our initial supplier evaluation was performed and Extract Technology (ETL) qualified to initiate a front-end design study together with us. Within a period of 3 months the study was completed including a full scale wooden mock-up trial at the ETL factory, ensuring the overall design and functionality of the isolator.
PPL decided to procure the isolator from ETL in alignment with the results of the design study. From date of order until completion of installation and SAT Polypeptide has met a dedicated, and collaborative, team of ETL personnel. From our perspective ETL has shown a “willingness” to resolve issues raised, suggest rectifying actions and strive towards the mutual end result.
There are a number of positive notes made throughout this project, I do take the liberty to mention a few of those:
· The solution brainstorms held during the design study and ETL’s willingness to share “lessons learned” and “best practice” making sure decided engineering solutions were robust.
· The “extra mile” taken to ensure a fully CIP-able analytical scale installed inside the isolator.
· Several follow-up calls from the local agent as well as from ETL sales throughout the project/delivery.
As an end summary I must say that it´s been a smooth and painless journey together with ETL. Pricing has been found to be comparable and realistic in comparison with similar competitors. We do look forward in doing business with ETL again in the future.
Manager, Engineering department
For further information of our services and machinery please visit:
Or for specific area details:
· Peter Devenny – Extract Technology
· Martin Gambel – Polypeptide http://www.polypeptide.com/
· Patrick Muller – Rommelag-FLEX https://www.rommelag.com/en/
· Mike Fenner – Pharmatech http://www.pharmatech.co.uk/
· Aleksandra Tambor – Extract Technology