Cleanroom training at Lonza: a successful collaboration
Lonza, one of the world’s largest contract development and manufacturing organizations (CDMOs), specialized in cell and gene therapy, called upon the expertise of Normec Advipro. Due to the signing of new contracts, the demand for additional personnel increased, leading to an urgent need for a structured and effective training of new employees. Particular priority was given to the training of cleanroom operators working in grade A and B environments.
Although training materials such as SOPs, work instructions, and batch records were available, there was a lack of specific hands-on experience and instructional skills to bring the new employees to the required level. That’s where Normec Advipro came in.
Expertise and infrastructure of Normec Advipro
Thanks to many years of experience in aseptic handling, cleanroom behavior, GMP and GDP, Normec Advipro was able to provide the client with the right knowledge and practical guidance. Since 2017, the company has had a modern GxP Academy with an integrated cleanroom for training purposes. This professional learning environment has led to successful collaborations with various pharmaceutical partners and is supported by a highly qualified training team.
With a background as a bio-engineer and over 24 years of experience in the life sciences sector, including roles in R&D, cell culture, and quality management, I am now active as Expert GxP trainer within the GxP Academy. My passion for knowledge transfer formed the ideal foundation to successfully support Lonza.
Smooth Integration into the client's environment
One of the main challenges was to quickly become familiar with the client's procedures and infrastructure. Fortunately, we soon discovered that Lonza had a well-structured training plan, complete with thoroughly prepared documentation and a well-thought-out training environment. After thoroughly reviewing the process and the training package, we were able to start delivering training sessions on aseptic techniques immediately.
Contents of the Aseptic Technique Training module
The module on aseptic techniques included the following components:
Material transfer: Preparation and cleaning of materials for use in the biosafety cabinet (BSC), including correct transfer from grade B to grade A and cooperation between two operators.
Starting up the BSC: Brief introduction to how a BSC works, including cleaning and proper layout of the workspace.
Pipetting: Proper use of a pipetboy, attaching a pipette, and careful fluid transfer.
Micropipetting: Explanation of how a micropipette works, how to clean it, adjust the correct volume, and perform accurate fluid transfers.
T-flask Handling: Handling of T-flasks within the BSC, including seeding, fluid transfers, and correct storage.
Bag Handling: Working with MPC and porous bags, including connecting and disconnecting Luer locks.
Spiking: Safe and aseptic use of needles for fluid transfers, including working with septum-sealed vials and syringes.
Outcome: individual training of dozens of new Employees
Thanks to the smooth collaboration with Lonza’s internal colleagues, we were able to individually train dozens of new employees. The close alignment and practical approach ensured that all training sessions were successfully delivered and met the client’s high standards.
Client appreciation
The collaboration was highly valued by the client, as shown by the following testimonials:
“We have completed the ramp-up for this project, meaning that the onboarding training is finalized. I would like to take the opportunity to thank you for the fantastic work over the past months. The training was always delivered according to the high standards we maintain here. Thank you very much, especially to Sven. For now, we have the staff we need on site, but rest assured that if we require additional support, we will certainly reach out to you again.” — Operational Excellence Training Lead
“Thank you very much for your support and excellent training performance. It was key to our program’s success and is greatly appreciated!” — Head of Operational Excellence
Writen by Sven Wuyts, Expert GxP trainer
More about Normec Advipro
Normec Advipro
Lille Belgium