An intelligent monitoring system is required when preparing sterile products to minimise risks for employees and patients and to provide the producer with maximum legal security. For this reason, the pharmacy Burg Apotheke in Königstein, Germany, has invested in an image-based weisstechnik monitoring system for its new sterile laboratory
Sterile products frequently have to be prepared specifically for patients. In some countries these are known as Specials and due to their short shelf life, the products are often produced in pharmacies that have their own cleanroom. In such cleanrooms, it is important to have a comprehensive overview of the production processes to exclude all potential sources of error that could compromise the sterility or efficacy of the products.
As the producer of patient-specific parenteral solutions, Burg Apotheke is committed to the highest requirements of cleanliness, quality and service. Ready-to-use products are prepared in its laboratory in accordance with the ApBetrO (Apothekenbetriebsordnung or German pharmacy operation ordinance) regulations.
In the field of parenteral drug production, a 2012 modification to the ApBetrO brought it into line with the EU GMP regulations. As a result, Burg’s cleanroom was extended and provided with an innovative monitoring system that records images in addition to the usual process data.
Weiss Klimatechnik was commissioned to carry out the project. As an established cleanroom specialist, the company has carried out more than 100 projects in the field of GMP cleanrooms. This experience gave Weiss Klimatechnik an advantage in the planning and implementation of the project, particularly, in regard to defining the sampling and monitoring points and the avoidance of possible sources of error.
However, Burg Apotheke’s particular requirements for Specials create some unique challenges. With a total footprint of 200m2, a 150m2 qualified cleanroom area was installed leaving a 50m2 (non-qualified) area for equipment and adjacent spaces. In the production area there had to be space for five clean workbenches and an isolator.
In the first stage of the expansion, the GMP production cleanroom was to be set up for cleanliness classes EU GMP A in C, as per ApBetrO. If required, at a later date it can be converted for production in cleanliness classes EU GMP A in B and for production in accordance with the German Medicinal Products Act (Arzneimittelgesetz).
Other considerations during the design and planning included: provision of a vestibule, along with personnel and material airlocks, as well as calculating the required dimensions of the ventilation components.
For structural reasons, the room was equipped with a compact air conditioning unit with its own integrated cold-water chiller. This achieved the aim of increasing the operational safety of the cleanroom system by maintaining its independence from the external supply media.
The system works in recirculation air mode with process-dependent outside air. It uses additional filter fan units with H14 high-efficiency particulate air (HEPA) filters in the production room and a separately controllable preparation room. Thus the required temperature and cleanroom class were generated in the sterile laboratory.
The new cleanroom has a compact air conditioning unit with its own integrated cold water chiller
An innovative monitoring system was installed to identify any process deviations and contamination at point of use as quickly as possible, so that they can be addressed immediately.
The easy-to-use, reliable control and operating software provided monitors all relevant standard values. In this way, temperature (with an upper limit of 25°C), humidity, room pressure and particle load are recorded. The EU GMP-conforming particle monitoring system measures particles sized 0.5µm and 5µm using an isokinetic sampling probe within the workbenches.
Furthermore, the patent-pending monitoring function takes images during the process for documentation of the process. Depending upon its settings, the images are taken by the system at defined time intervals or on an event trigger and each one is time stamped. Combined with the further sensor data, it means that the production of each batch can be accurately tracked. It provides the manufacturer with uninterrupted tracking for every batch and therefore the highest legal security. With the new monitoring system it is possible for the first time to prove what the conditions were and what events occurred for any point in time. When complete, a total of six cameras are planned for the work stations.
The S!MPAC control is the centrepiece of the monitoring system. It has web visualisation and additional interfaces to laboratory equipment which can be used to connect scales, e-sign or a bar-code scanner, for example.
For Burg Apotheke, the new, upgradable cleanroom with its monitoring system provides the pharmacy with optimal production conditions for the present, yet with additional options for the future.
The Weiss Technik group of companies, which are part of the Schunk Group, provide solutions that are used around the world in R&D as well as in production and quality assurance. Products include environmental simulation, heating, air-conditioning and containment solutions. Weiss Klimatechnik provides air-conditioning solutions wherever optimal climatic conditions are required.
S!MPAC and S!MPATI are registered trade marks of Weiss Technik