Name: Calvin Malone

Role at Lennox: Product Specialist — Single Use Systems & Fluid Technology

Background/Education: Graduated with a B.Sc. Biological & Biomedical Sciences from Maynooth University in 2019 and currently undertaking a Level 9 Post-Graduate Certificate in Biopharmaceutical Processing, via NIBRT. Previous lab experience working as a Research Assistant with the Metabolic Immunology Research Group in Maynooth University.

What are your areas of expertise?

I specialise in high purity process tubing, single-use disposable systems, integrated fluid path components, peristaltic process pumps and final fill/finish consumables.

My goal is to understand the specific requirements of each end user, and work with them to develop a solution. The objective is to increase manufacturing efficiencies and assist in the integration of total process solutions for our customers.

What sectors do you work with?

Our product range is adaptable between a variety of sectors; I work closely with different markets including Biopharmaceutical, Pharmaceutical, Food & Beverage, Life Sciences and Industrial.

What challenges are currently facing the customers you work with? How are you helping them overcome those challenges?

1) Speed and supply chain

The process of creating a fully bespoke, customised single-use assembly can be a long one. Challenges faced in design, material sourcing, testing and validation can result in a time frame of 16 to 20 weeks from initial enquiry to customer delivery.

Lennox employs a 3-step system to ensure quick turnaround times:

1. Design

Lennox BioProcess engineers create single-use systems designed to meet your specific requirements.

2. Prototype

From your unique drawing, a rapid prototyping process is initiated to produce working samples for immediate evaluation and functionality testing.

3. Assembly and Packaging

The disposable system will be assembled, labelled, and packaged in a controlled environment according to cGMP protocols.

2) Extractables & Leachables

The purity of pharmaceutical products is of the utmost importance and determining where impurities can arise is critical. Migration of mobile chemical species from components used in the manufacture and storage of pharmaceutical products is a potential cause of impurities. These mobile chemical species are known as extractables and leachables. We work with end users to ensure the most suitable materials are chosen for their specific application to limit extractables and leachables in their process.

3) IQ/OQ

In the Biopharma and Pharma industries, reliable equipment is vital. Many customers in these sectors require Installation Qualification/ Operational Qualification on their process pumps.

Lennox engineers offer this service on the process pumps which we supply. The customer receives a signed copy of the protocols ensuring that all necessary tests have been completed and passed.

What are some key trends you are seeing in your area of expertise?

· Supply Security

There is a push in the pharma and biopharma industries to condense the number of suppliers they use and ensure stability of supply chain. Lennox have adapted to this by increasing our product range, offering equipment including peristaltic process pumps, process tubing and fluid path components. In addition to our expertise in developing customised single-use systems, meaning we can assist in total process supply.

· Further Integration of Single-Use Systems in Process

Stainless steel facilities still hold a big share of the market. I feel that the benefits of single-use systems are becoming clearer and there is a push to move to a 100% disposable bio-manufacturing system.

If you would like more information on how Calvin and the rest of the Single Use Systems and Fluid Technology team could assist your organisation, email calvin.malone@lennox.ie.