Partially and fully automated approach systems
SCHRADER Approach Systems
SCHRADER supplies partially and fully automated systems for the batch preparation of liquid or semi-solid products for the pharmaceutical and food industry.
The engineering focus is on particularly critical parameters such as the cleanability of the system and the prevention of cross-contamination. The decisive factors here are the surface quality and the “hygienic designs” in accordance with the EHEDG standard, such as compliance with the 3D rule and avoidance of non-flowing outlets in product and ultrapure media-contact lines. Therefore, the stainless steel containers and the associated fittings are electropolished and a surface roughness of Ra < 0.8 µm guaranteed. In order to optimise the cleaning result, we rely on floating magnetic agitators, NovAseptic® connectors and ingold connectors for the design. Depending on the requirements and intended use, the containers are made of stainless steel types 1.4404, 1.4435 or 1.4539. Other steels and materials are also possible on request.
The engineering focus is on particularly critical parameters such as the cleanability of the system and the prevention of cross-contamination. The decisions here include the following:
Materials and surface finish
Design and construction
Acceptance test certificate 3.1 for all materials in contact with products and with pure media
Hygienic/Aseptic design according to EHEDG standard
FDA declaration of conformity for seals in contact with products and with pure media
Compliance with the 3D rule
Stainless steel tanks as well as the associated fittings are electropolished with a surface roughness of Ra < 0,8 µm
Avoidance of non-flowing outlets in lines that come into contact with products and ultra-pure media
Depending on requirements and intended use, the containers are made of stainless steel types 1.4404, 1.4435 or 1.4539. Other stainless steels and materials are available on request.
Purpose-built installations, such as (floating) magnetic agitators, NovAseptic® connectors and Ingold sockets for better cleanability.
The degree of automation for the system is freely selectable:
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.
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