Tuesday, January 9, 2024
February – Retrofit L2
The retrofit of L2 meant to replace the product pipeline of Line 2 with a mobile/portable solution for sterile filtration and change the concept of sterile filtration (redundancy) at the same time. The solution consists of three main parts, a mobile vessel, a filtration skid and a TCU (Temperature Control Unit). Since we had to replace the aseptic part, i.e. a very risky part of the production equipment, we decided that we had to preserve the functionality of the original product pipeline. The assignment for this project was a big challenge, because in this project, we had to solve audit findings and compliance with regulations (including the new annex 1) and significantly reduce API losses during production and, last but not least, prepare Line 2 for a central formulation area. At the same time, the retrofitted line had to be able to produce both aqueous and non-aqueous products (organic solvents).
June – New formulation vessel for Line 1
We introduced a new stationary formulation vessel with a volume of 1,500 litres labelled as K1 for the formulation on Line 1. Given the fact that all the formulation processes will be transferred to the Central Formulation area in the near future, it would not make sense to purchase the same vessel again as it would soon cease to be usable in the Central Formulation area. The new vessel was designed and optimized so that its placement on Line 1 required only minimal interventions in the cleanrooms, in the media distribution and shells, to automation, to processes, to the operation of the vessels and the formulation of solutions.
August – FAT of Line 3
The main goal of the FAT was to verify the production procedures that will be routinely performed on individual devices. This verification was carried out with regard to a large set of processes – production preparation, the filling process and final cleaning after the production. At the same time, both the functionality of the device and the practicality and feasibility of individual actions were in focus. Filling different doses of the product was a key part of the testing. Dosing accuracy was examined as it is a fundamental factor in ensuring the quality of the final product. In addition, the precision of filling and stoppering – key aspects that ensure that each syringe is filled with the correct amount of product and properly closed – were verified. After completing all the steps mentioned above, the FAT was evaluated as successfully completed.
September – The release of the first non-financial reporting
The release of the first non-financial reporting based on environmental, social, and governance criteria represented a pivotal milestone in corporate transparency and accountability. For our company, this release signifies a shift away from the traditional focus solely on financial results towards a more detailed disclosure of our impact on the environment, social issues, and corporate governance. This report contains information about our environmental initiatives, such as efforts to reduce carbon footprint and utilize renewable energy sources, as well as our approach to employee rights, diversity, and social engagement within the community.
September – Launch of RABS
RABS (Restricted Access Barrier System) is a technological solution that combines the advantages of traditional cleanrooms and isolators. It is designed to minimize the risk of product contamination during production processes while increasing production quality and efficiency by limiting the access of personnel and other sources of contamination to critical production areas. From perspective of Annex 1 and our customers, it is a necessity that we have to implement if we want to continue with production on line 1. As with most new technologies, the introduction of the RABS required a significant initial investment. A big challenge was the correct installation of the equipment itself, as it required a complex reconstruction of the production area. However, the final qualification confirmed that the RABS is working in accordance with the expected parameters.
October – Pie Collection for Hospice
The Pie Collection for Hospice is a poignant and essential initiative that unites the community in support of those who need our care and assistance on their challenging journey. By contributing to this collection, we become part of the mission to provide help and support to those going through difficult times. Together with BioVendor, we managed to raise a record-breaking amount, nearly 25,000 Czech crowns. The proceeds from this year’s charity event will be utilized by the hospice for enhancing care, procuring medical supplies, and medications.
November – Signing the memorandum
Joining the Pride Business Forum embodies our commitment to embrace our fundamental values – HUMAN and OPENNESS. Within these values, we wholeheartedly champion equality, celebrate diversity, and encourage courage. Our unwavering objective is to honor and appreciate every individual solely on the basis of their humanity, irrespective of distinctions like gender, race, nationality, religion, age, education, and beyond.