FAQ
Containment means the sealing of hazardous substances. The containment of hazardous substances is important from two aspects. Firstly, personal protection should be ensured by preventing any substance from escaping during the production process, secondly, the product must also be protected from contamination or the entry of other substances to prevent contamination or cross-contamination.
A containment split butterfly valve consists of two separately closed interfaces that, after connection, allow the transfer of bulk materials without emissions and thus guarantee the protection of both people and product.
Split butterfly valves are used in the pharmaceutical, chemical and food industries whenever special protection is required for both the operator and the material that is being processed. As a rule, these are highly potent active ingredients that have to be handled under controlled conditions, for example the introduction of an API into a reactor or the emptying of big bags into smaller containers.
The multi-use technologies from Andocksysteme G. Untch are valves that are usually made of stainless steel and designed for continuous use.
The single-use technologies from Andocksysteme G. Untch are valves and packaging solutions made of FDA-compliant plastics and intended for single use.
The introduction of undesirable chemical or microbiological impurities into a raw or intermediate product or an API, for example through production processes such as sampling, packaging or repackaging, or during storage or transport.
Cross-contamination is the contamination of a material or product by another material or product.
To ensure containment, it is important that the production plant, including the interfaces between the production plants, represents a closed system. The prerequisite for this is that there is no connection between the environment and the interior of the system in order to avoid the escape of substances (e.g. hazardous substances according to Article 10 GefStoffV [German Hazardous Substances Regulations]) from the closed system.
Due to the sophisticated and proven design of our interfaces, a closed system and containment can be guaranteed at any time in the process – whether docked or undocked. This also applies to cleaning. Optionally, it is possible to equip the interfaces with extraction devices or to prepare them for use in areas with potentially explosive atmospheres.
CIP is the abbreviation for “Cleaning in Place” and describes the fully automated cleaning of a system that requires no disassembly and no additional manual cleaning steps.
“Wash in Place” is the automated system cleaning where, compared to “Cleaning in Place”, additional manual cleaning steps follow.
SIP means “sterilisation in place” and describes the localised automatic sterilisation of plants and subsystems. The SIP process is usually performed after the CIP process and is temperature, pressure and time dependent.
Autoclaving is the non-localised sterilisation of equipment in an autoclave, which essentially consists of a pressure vessel, a water supply and a heater.
The SMEPAC test is a standardised test for the determination of air and surface dust limit values – the so-called OEL value – for plants and equipment, which has been adopted from the ISPE guideline “Assessing the Particulate Containment Performance of Pharmaceutical Equipment”. SMEPAC stands for “Standardised Measurement of Equipment Particulate Airborne Concentration”.
API is the abbreviation for “Active Pharmaceutical Ingredient”. This term is used worldwide in the pharmaceutical industry.