Bosch Introduces CIP System for Use with Human Vaccines
Product News Oct 01, 2014
At TechnoPharm 2014, Bosch Packaging Technology presents the special version of a CIP (Cleaning in Place) system.
“The exhibited system serves for cleaning and wastewater inactivation of various process systems used in the production of human vaccines,” explained project manager Volker Kempf. “It meets the highest safety requirements.
In addition, it is easy to transport, quick to set up, and easy to handle.” The CIP system is manufactured by Pharmatec, a subsidiary of Bosch Packaging Technology.
The development of human vaccines comprises three successive process steps: preparation, purification, and formulation. During the first phase, eggs are inoculated with virus-containing material for selective replication of viruses in the laboratory. To separate the viruses, the egg-based preparation is purified in several steps by means of filtration and addition of buffer solutions.
The CIP system from Bosch is used for cleaning the pharmaceutical purification equipment, which ranges from the harvesting system to a variety of filtration and separation systems to the process tank with finished active substance concentrate, and at the same time thermally inactivates the wastewater.
Operator safety is the highest priority Handling of live viruses poses a threat to the staff and requires high equipment security measures. Consequently, the CIP system and all system modules are designed according to biosafety level 3 (BSL 3). To keep viruses from escaping to the outside, Bosch has designed a completely closed system with fixed piping and a hermetic CIP pressure vessel.
The pumps for supply and return of rinsing media are equipped with double mechanical seals and sealing liquid (pure steam condensate) in the space between the seals, ensuring that no contaminated cleaning media escapes into the environment.
Easy operation with the touch panel
The system in compact skid design provides essential advantages to the user: Due to its modular construction, it can be transported easily, as well as set up and connected to the media supply of the building quickly. If production is moved to another location, the system can be reinstalled at the new site without difficulty. The touch control panel with a user-friendly menu enables simple parameterization of the cleaning program. All components and parts coming in contact with the media are made of stainless steel and fitted with a high-quality surface. Hence the system can clean itself without residue between applications, and can be sanitized with water for injection (WFI) at a temperature of 125 degrees Celsius.
As a satellite system, the CIP system is designed for cleaning of various process systems on a rotating basis, as well as for cleaning of tubing or loops. With a volume of 800 liters, the CIP tank has the necessary size to clean process tanks with a useable volume of approximately 2000 liters.
Sodium hydroxide, which is prepared in a separate tank, is used as the cleaning medium.