SPE Series - New closure processing equipment
- The machine body and jacket are completely made of AISI 316L stainless-steel.
- AISI 316L stainless steel piping is connected with ASME tri-clamp connections.
- The machine body is insulated with ceramic material and with an external cladding of stainless steel.
- Minimizing particle generation due to mechanical stress and effective endotoxin reduction.
- Uniform silicone distribution on individual stoppers and the entire batch.
- The control system monitors, records, and controls the operation of the equipment.
- Customized cycle according to client requirements.
- Equipment is engineered and manufactured to optimize running costs, saving utility costs.
- Ten different loading and unloading solutions are offered.
Automatic loading is undertaken using a: stopper storage tank with mixer, suction tube, measuring tank with sanitary valves and aspirator. Manual loading is carried out using AISI 304 stainless-steel containers of the same capacity as the machine baskets.
Possibility to interface the unloading door with wheeled tanks, containers, sterile transfer bags and HPV (hydrogen peroxide vapor) isolator. Unloading door equipped with a system for interfacing with clean area (bio-seal frame with “FDA approved facilities”). Chamber doors made in accordance with requirements for sterile environments.
Special applications: automatic unloading into Sartorius Bio-safe clean pre-sterilized bags through Biosteam port.
Compliance and guidelines:
European Directives: 2006/42/EC; 2004/108/EC; 2006/95/EC; 97/23/CE; ATEX 94/9/CE. European Standards: EN 12100-1-2, EN 13857, EN 349, EN 61000-6-II-IV, German version EN 61000-6-4; EN 55011 (ISM); EN 61000-4-II-IV (IEC); AD 2000; EN 60204-1 (IEC 204.1); EN ISO 11135; EN 1422. North American Standards: OSHA; NFPA (when applicable: FDA; UL; ASME). Canadian Standards: CSA; CRN. Russian Standards: GOST.
Software is developed in compliance with current coding rules and programming and according to standard ISA 88, ISA 95, IEC 61131-3 standard & GAMP 5.