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ProSys Technology specialise in the design, manufacture and validation of Isolators and RABs systems to meet the ever-changing requirements of the Pharmaceutical and Biopharmaceutical industries.
One of the most critical pieces of equipment for many laboratories is a lyophiliser, also known as a freeze dryer. Lyophilisers are typically used in a range of industries, including Pharmaceuticals and Biopharmaceuticals. In this case study, we will take you through each stage of a successful Isolator assembly project we completed for a client, from the concept of the freeze dryer to factory acceptance (FAT) testing.
A lyophiliser Isolator is a specialised enclosure that is designed to protect the product being dried from contamination. The Isolator provides a controlled environment with a lower particle count than the surrounding room. Isolators can be either positive pressure or negative pressure. Positive pressure Isolators have air flowing out of the enclosure, while negative pressure Isolators have air flowing into the enclosure.
Many lyophiliser Isolators have a glove box system that allows the operator to manipulate the product without exposing it to the surrounding environment. The glove box system is a sealed compartment with gloves attached to the front of the Isolator. The operator can reach inside the glove box system to handle the product without needing to enter the Isolator.
Using a lyophiliser Isolator can provide numerous benefits for laboratory work. First and foremost, the Isolator provides a clean and controlled environment that minimises contamination. This is especially important when working with biological samples that can be easily contaminated.
Lyophiliser Isolators consist of several key components that work together to provide a controlled environment. These include the chamber, the glove box system, the air handling system, and the control system.
The chamber is the area where the product is placed for drying, designed to provide a sealed environment that minimises contamination. The glove box system allows the operator to manipulate the product without exposing it to the surrounding environment. The air handling system is responsible for maintaining the controlled environment within the Isolator. This system filters the air entering the Isolator to remove particles and other contaminants. The system also provides either positive or negative pressure to the Isolator, depending on the type.
Finally, the control system is the brains of the Isolator. This system manages temperature, humidity, and pressure within the Isolator to maintain the desired environment for drying the product.
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Our lyophiliser Isolator project started with the receipt of the initial User Requirement Specifications (URS) from the client. ProSys Technology’s experts, together with the client, developed initial conceptual layout sketches. The team studied and analysed the challenging room layout restrictions and identified the optimum layout that would work best for the project while providing good interfaces with integrated third party equipment.
To ensure that the work process could be carried out safely and ergonomically, a timber mock-up was built from the sales design solution. This enabled the team to prove out all required operator interactions. Once this was done, the team developed 3D CAD drawings to guarantee all dimensions were thoroughly checked before the start of in-house fabrication.
After the completion of the 3D CAD drawings, the team proceeded with the fabrication of the Isolator. Once the fabrication was complete, the Isolator was thoroughly checked for all relevant third party interfaces, and the operational performance of the Isolator assembly was proven. Specific checks were made on the dosing valve, weigh scales, RH / temperature controlled atmosphere, containment performance testing (CPT) to achieve ≤0.1µg/m, and integration of the client-supplied IBC. All of the above checks were completed before sending the Isolator to the site, ensuring minimal downtime during site installation.
Testing a lyophiliser Isolator is a critical step in guaranteeing the equipment is reliable and meets the needs of the laboratory. Testing should always begin at the concept stage and continue through to the very end! Factory acceptance is pivotal to the design and manufacture processes, this allows the Isolator to be tested in a simulated operating environment, confirming it meets the specifications outlined in the design.
The success of this project can be attributed to the expertise and experience of ProSys and their experts. They were able to deliver a quality and efficient solution that met the client’s requirements. The company’s attention to detail during conceptualisation, design, and fabrication stages ensured that the Isolator’s assembly was safe, ergonomic, and fully functional. ProSys Technology continues to deliver quality processes, products, and solutions to their clients.
Choosing the right lyophiliser Isolator is key, take a look at our product library here. If you have any queries or projects, do get in touch today. Contact us via email, by clicking here, or pick up the phone for a chat on +353 (0) 21 485 3900.
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