CIP/SIP System

Product Details

Modular Cleaning in Place (CIP) and Sterilizing in  Place systems (SIP)

Cleaning in Place and  Sterilizing in Place systems are essential parts of every quality-conscious  manufacturing of pharmaceutical products. Cleaning-In-Place (CIP) and  Sterilization-In-Place (SIP) are systems designed for automatic cleaning and  disinfecting without major disassembly and assembly work. Additionally, a well  designed CIP system will enable you to clean one part of the plant while other  areas continue to produce product. Furthermore, a modern CIP system will not  only save money in terms of higher plant utilization but also due to significant  savings in CIP liquid (by recycling cleaning solutions), water (the system is  designed to use the optimum quantity of water) and man-hours.

The cleaning can be carried  out with automated or manual systems and is a reliable and repeatable process  that meets the stringent hygiene regulations demanded by the biotechnology and  pharmaceutical industries. Other benefits of a well designed CIP plant includes:  operator safety (operators are not required to enter tanks and vessels to clean  them and potent cleaning materials do not need to be handled by operators), and  downtime (if any) between product runs / product changeover is  minimized.

GMPMax provides  high-performance cleaning and sterilization concepts that are individually  adapted to the client's very specific requirements.

GMPMax verifies whether one or  multiple CIP cleaning vessels are required on the modular to achieve the maximum  cleaning effect for each plant. The cleaning steps are specifically configured  under consideration of the kind of product to be manufactured.

From mobile or stationary  cleaning systems up to CIP satellites fed with conditioned cleaning media from a  central unit – the variety of special solutions for your process plant is vast.  

Prerequisite for the  manufacture of sterile liquid pharmaceutical products is that loop and machine  systems are kept sterile. It is imperative that all equipment coming into  contact with the product must be subjected to a documented  temperature-controlled sterilization procedure with hot media.

Sterile production requires  sterile plants. In the pharmaceutical industry, sterilizing in place is done in  almost all cases by using saturated steam at a pressure of 1 bar. After  sterilization, a system in contact with steam has to be cooled down. This is  done by means of blowing out the system with sterile air and, in case of process  vessels, the cooling system via the jacket is activated.

Having ended the SIP process,  all sensitive components have to be checked for their proper functionality and  integrity. This is most important in the case of filters that have been used for  a sterile filtration.

GMPMax has extensive  experience with sterile processes for almost every task. Safe production lines  and safe connection points to the related process or filling machines along with  an efficient and time-saving procedure are of vital  importance.

The design  of CIP systems for the Biotech and Pharmaceutical Industries requires an  in-depth knowledge of handling high quality water, as well and the process  knowledge to clean high quality process equipment in a safe, effective and  repeatable way. The flows and pressures required to clean process vessels;  pipework and equipment must meet  GMP standards and specifically confirm:

a)      Mechanical Action through turbulent flow in pipework and spray devices in  vessels. The GMPMAX system monitors both flow and pressure to confirm these  variables.

b)      Chemical Action through in line dosing of detergents. The detergent  strength is confirmed with on-line conductivity monitoring. The GMPMAX system  also monitors final rinse water conductivity to confirm that the detergents have  been removed from the circuit being cleaned.

c)      Temperature through the use of jacket vessel to produce hot water or a  CIP skid heat exchanger with temperature control and  monitoring.

d)      Cycle sequence and time through the PLC based control system. The GMPMAX system  uses a touch screen HMI and is easily programed so that the client can build new  CIP recipes.

Key Words for CIP/SIP  Systems:

Cleaning in  Place, Sterilizing in Place systems, CIP, SIP, Sterile Products, automatic  cleaning and disinfecting, CIP system, sterile plant, CIP/SIP/DIP SYSTEM,  cleaning, sterilization & drying in place,
Pharmaceutical industry, sanitary design, GMP compliant  design,
Purified water  rinse, Alkali solution recirculation cycles, Acid or hypochlorite  neutralization, Purified Water recirculation cycles, WFI rinse, pure steam  sterilization, sterile air blowing