Telstar has released a new single-vessel good manufacturing practice (GMP) production freeze-dryer that is optimised...
Pharmaceutical company Orion entrusted Telstar as a specialised partner in containment technology to supply various isolators to sites in Finland over the last five years.
All of the containment isolators were designed and manufactured by Telstar in the UK as multi-chamber units to contain specific operations related to sampling, dispensing, mixing and blending of multiple active pharmaceutical ingredients (API) and excipients for a wide range of products.
The package of isolators was recently completed with a unit that saw the mixing of liquids and blending of powders. It was introduced into their process requirements. A challenging technical requisite solved by integration of a multi-purpose docking port for the mixing and blending requirements, a height adjustable ATEX rated mixer, heater pad and split butterfly valve.
A key challenge for all the projects was that the isolators had to be designed for multi-product with multiple sizes and shapes of containers, including good manufacturing practice (GMP) and cleanability as one of the most relevant issues in order to avoid cross-contamination.
Telstar incorporated a semi-automatic detergent wash system to clean and dry the isolators in a short time for a faster changeover from product to product. In addition, the weighing requirements were very stringent and it was essential that the weighing system had to communicate directly with the dispensary management system of the pharmaceutical company.
In some cases, the pharmaceutical process required to weigh the product into bags via split butterfly valves, however, the exposure level the valves were capable of attaining was deemed too limited.
Consequently, Telstar enclosed the offload process in a dedicated isolator chamber, which presented additional ergonomic issues due to the operator position and the weights involved. To solve this issue Telstar provided a unique lifting system coupled with a live product weighing station.
Each and every Isolator underwent thorough ergonomic trials with Orion’s operators to ensure all aspects of the processes involved were considered and indeed possible in the final design. Finally, all the isolators have been designed and manufactured with multiple filtration and fan systems to maintain stringent operating parameters.
Sales manager at Telstar’s technology centre for barrier isolation systems in Dewsbury Tony Rhodes said: “One of the most positive points from all the five contracts is that the key people from Orion and Telstar have stayed the same throughout. The relationship and understanding of each other have developed over the last six years, including the workshop and site technicians at Telstar, who know exactly what the client expects from each isolator.”
The Orion Corporation is a globally operating Finnish pharmaceutical company that develops, manufactures and markets human and veterinary pharmaceuticals, APIs and diagnostic tests.
Continuously developing new drugs and treatment methods, the core therapy areas of Orion’s pharmaceutical research and development (R&D) are central nervous system (CNS) disorders, oncology and respiratory diseases that can be treated by Orion’s inhaled Easyhaler® pulmonary drugs.
Headquartered in Espoo (Finland), the company operates in more than one hundred countries. Listed on Nasdaq Helsinki, the Orion Corporation was founded in 1917 and currently has a workforce of 3,500 people.
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