An experienced sound engineer is an important part of a band during a “gig”. New locations, different acoustics and usually little time to fine-tune. Like parameters, which are a big part of the sterility process for a sterility test isolator (STISO). Lead-time for this process is not just a few hours, but several months. Timing was a critical factor during a project for a well-known global pharmaceutical company, for their new “gig”.
New sterility test capacities were needed for a new production facility and time was of the essence, since the installation was delayed due to reasons beyond the company’s control.
While finalizing the project was imminent, the timetable was getting tighter. A most precious criterion was the delivery time, remembers Kenan Kanmaz, who received an inquiry while he was on vacation in August 2019. Two days after his return he met with experts from the customer and a specification was sent immediately to Metall+Plastic in Radolfzell. Including a very tight timeline for the required sterility test isolators. The first sterility test isolator for this customer was required to deliver in May 2020. In addition, all quotations and pre-order provisions had to be completed within two weeks.
Gerhard Breu, Chief Representative (Optima Pharma) and the former Managing Director Thomas Bertsche (Metall+Plastic) needed to decide if Metall+Plastic was going to accept this challenge. After several discussions, they decided to take the project on. Besides the timeline, quality machinery, process safety and fast decontamination were the customer’s key requirements.
Originally, five sterility test isolators were expected to be required for the new facility. However, after reviewing the specifications for the loading capacities more closely it was evident that the customer would only need three Metall+Plastic STISOs.
In terms of the short delivery times specified by the customer, Metall+Plastic was depending on their special technical STISO designs. A crucial element was the modular design that adapts easily to individual environmental conditions. For example, the capacity and number of glove ports, as required in this project, can be maximized. The customer decided to purchase four glove ports, the largest alternative.
Ergonomics is an important part of a STISO in order for employees to reach all areas and work without fatigue. The STISO’s ergonomic design creates a comfortable work environment for operators of any height. In addition, it does not require a mock-up, which decreases delivery time and overall cost compared to customized STISOs. Three modular STISOs rather than the five originally planned sterility test isolators were a convincing package – and Metall+Plastic was able to reduce the project timeline using three identical systems.
The STISO is designed to fit in different room configurations and is suitable to sit flush with the ceiling, sideways flush in a corner, or back to back in the middle of a room. The latter two alternatives were implemented for this project. Only a few connections were required to connect the STISOs to the existing building structure, with compressed air, cooling water and power. Therefore, the STISOs will operate independently from environment temperature due to an integrated cooling coil that compensates high room temperature and lowers the temperature to levels according to defined process parameters and tolerances. The process temperature can be lowered to 18 °Celsius. At the same time, the cooling unit ensures that no heat is released into the room. Like the modular design, this is a unique feature to help meet customer requirements.
The customer also had particular requirements to process internally defined error messages. Specific identical error codes alert operators and technicians about malfunctions; Metall+Plastic adjusted its software accordingly. Consequently, detailed documentation was created according to customer standards.
Metall+Plastic offers a very high standard for process quality and utilized components, including controls. In correlation with specific design features like service-friendly door sealing systems, work chambers and MTC’s in 316L stainless steel, sterile design, air filtration systems and comprehensive sensors with different alarm functions, very high process safety is ensured using the sterility test isolator.
With the start of the Coronavirus, an unexpected obstacle emerged. Specifically concerning the cycle development. Many projects were delayed due to the first hard lockdown. Customers, understandably, did not want and could not have external personnel in-house. Once it was feasible to visit customers again, a long list of projects had to be managed. Even so, Metall+Plastic was able to keep the timeline for the FATs and SATs, as well as the start-ups.
The first STISO during the pandemic was installed in May 2020, as scheduled. The FAT for the second STISO took place in June and the FAT of the third STISO in September 2020. Due to reasons mentioned earlier, the cycle development was slightly delayed, but on time for production start. After the Process Qualification (PQ) of the first STISO in December 2020, the two remaining sterility test isolators were placed into the laboratory area only a short time later.
The pharmaceutical company selected the DecoPulse® bio-decontamination system from Metall+Plastic. One of the system’s features is the homogeneous distribution of H2O2 into the isolator and onto the surface of the loading station, while reducing H2O2 at the same time. This means less H2O2 has to be removed from the isolator. Due to the small micro droplets, the H2O2 becomes an atomization driven evaporation system using our patented DecoPulse® technology. The catalytic ventilation system from Metall+Plastic is an important feature to minimize the remaining H2O2 very quickly.
In summary: The sterility test isolator from Metall+Plastic will give you more production time. To put it in numbers: 49.0-gram H2O2 is injected during the entire decontamination process and it takes ten minutes to achieve a 10-log germ reduction. Subsequently, it only takes 35 minutes of ventilation time to reduce the H2O2 to a remaining 0.5 ppm concentration and only an additional 25 minutes for safety ventilation.
Due to the short cycle times and gained production time, the customer waived the loading port – saving space, as well as acquisition and maintenance costs. To maximize production time even more, four glove port tester covers, for the four glove ports, were ordered for each of the sterility test isolators. The GTS-WL is connected with the system’s HMI via WLAN and integrated in the machine’s design. The integrity testing time for all four glove ports per isolator is therefore reduced to 15 minutes. In addition, the systems can be operated independently.
Conclusion: Reaching your objective with the correct technology.