In order to comply with the rapidly changing regulations concerning the preparation of medicines in hospital pharmacies, we have developed HOSPIX. This mobile pharmacy ensures that hospitals can develop their cytostatic and sterile preparations in cleanrooms in accordance with the strict GMP-guidelines. The cytostatic section in the cleanroom is technically separated from the sterile preparations section, which excludes the risk of cross-contamination. The successive PAL and MAL areas ensure that correct changing procedures are followed and that the materials can be brought in the cleanroom correctly. HOSPIX is developed to be installed both indoor and outdoor and can be delivered within 7 weeks due to its standardized design.
ABN Cleanroom Technology offers audit services to verify your compliancy with the stringent PIC/s regulations. The objective of our PIC/s audit services and feasibility study is to provide a clear overview of the points that need to be adjusted to comply with the new PIC/s standard, including a clear budget estimate for the upgrade of your pharmacy facility. We elaborate an investment plan and a preliminary timetable of the different possibilities and alternatives to ensure compliancy with the new PIC/s directive.
In our audit services, we will assess existing pharmacies, cytostatic areas and existing air handling installations. A detailed audit report contains our findings & recommendations and will be delivered after finalizing the audit services. In our study, the following elements are identified and analysed:
At the end of last year, the PIC/s guideline for good practice for the preparation of medicines in healthcare institutions was included in a new Royal Decree in Belgium. On January 2023 latest, all Belgian hospital pharmacies have to meet increased quality requirements to guarantee the safety and quality of medicines and medical devices. In concrete terms, this means that the method for sterile preparations and cytostatics will be significantly tightened.
With an eye to the future, HOSPIX is a temporary or permanent solution for pharmacy departments in hospitals to ensure that medicines can still be produced in-house after Januray 2023. With external dimensions of only 12x11m and its mobility aspect, HOSPIX can be easily located outside on the hospital's premises. In other words, HOSPIX is a fully equipped mobile pharmacy for hospitals and other applications compliant with the PIC/s guideline as included in the KB20201214.
HOSPIX is equipped with ABN Cleanroom Technology's patented VIX concept (nr. 2820356). This concept holds on to a pre-engineered approach of the technical installations of each cleanroom in order to optimize the usable space, minimize energy costs and reduce the duration of the construction work. This cGMP environment ensures that products are consistently produced and controlled to the quality standards as required. The implementation of our VIX concept in HOSPIX pharmacies allows us to diminish the risks inherent to pharmaceutical production.
Additionally, HOSPIX is equipped with a CleanConnect IIoT system in order to gain insights in the environmental parameters of the PAL, MAL, the corridor, the cytostatics area and the sterile preparations area. A secure cloud platform accessible through a web-based interface allows the end-user to continuously monitor and create reports of the cleanroom conditions.
Founded in 1996, ABN Cleanroom Technology has many years of experience in wide-ranging industries. Our R&D team and innovation driven culture help us stay ahead in pre-engineered & circular cleanroom design.
With a Design - Build - Finance - Maintenance approach, our services range way further than only building a cleanroom. Our OPEX finance model allows us to offer you a cleanroom-as-a-service all-in model.
In a focus shift from a linear 'take-make-dispose model' to a circular model, pre-engineered and modular concepts are the key to success. Circular thinking involves the reuse of materials, but also of data and knowledge.
