CIP and SIP systems
Cleaning in Place (CIP)
Sterilisation in Place (SIP)
SCHRADER CIP / SIP systems
The EU GMP Guide, Chapter 3 defines the following essential principles:
- All equipment must be designed in such a way that it is suitable for the specified purpose and can be easily and thoroughly cleaned.
- Cross-contamination must be avoided by designing the systems accordingly.
- The systems must be qualified for their suitability and the process must be validated.
CIP / SIP systems are designed by SCHRADER in such a way that they are delivered in prefabricated skids and already have the required fully automatic cleaning operations at their disposal.
CIP (Cleaning in Place): Cleaning processes of the surfaces in contact with the product are carried out without complex disassembly.
SIP (Sterilisation in Place): The probability of sterilisation of the equipment used in accordance with the European Pharmacopeia by sterilising the surfaces in contact with the product with steam without complex disassembly. To ensure the success of the sterilisation process, the temperature at the coldest point of the plant is monitored and recorded.
Optionally, the system can be extended by a DIP process.
DIP (Drying in Place): The equipment is blown dry by compressed air or inert gas over a sterile filter for a defined time, so that the “clean hold time” is extended because no residual liquid remains. The equipment can be stored clean, dry and sterile.
Both the system and the visualisation with the stored operations can be customised to almost any requirement. Based on a well-thought-out authorisation concept, selected parameters can be specially adapted to optimise the cleaning process.
The execution is carried out in accordance with the regulations of the EU GMP Guideline Annex 11 “Computer-aided systems” and the “21 CFR Part 11 Electronic signatures, electronic records”. The software is categorised and validated according to GAMP5.”
SCHRADER supplies partially and fully automated systems for the batch preparation of liquid or semi-solid products for the pharmaceutical and food industry.
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