ProMach est votre partenaire du début à la fin. Nos marques de produits sont regroupées en secteurs d'activité distincts qui ont le plus de sens pour nos clients, couvrant toutes les fonctions de la ligne d'emballage: remplissage et bouchage, flexibles, manutention des produits, étiquetage et codage, fin de ligne et pharmaceutique.
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Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- cGMP
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- Eudralex
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
Chamber volume
from 330 litres / 11.7 cu ft
to 10.000 litres / 353 cu ft
Custom dimensions available up on request
Overall dimensions
The overall dimensions may vary according to machine configuration and customer’s requirements. Electrical cabinet may be installed remotely from the machine depending on space and operational requirements.
The unit has electrical heating elements and air recycling fan(s) positioned on top of the chamber. Pre-filters and HEPA filters are installed on the inlet and exhaust air ducts to prevent cross-contamination. Monitoring of chamber pressure and HEPA filters efficiency by differential pressure transmitters. Absolute filters' housing provided with accessories necessary for the DOP test. The air cooling is carried out by a heat exchanger running by chilled or softened water.
Differentially perforated walls, airspeed, and temperature control ensure an extremely air drying quality process. Tri-clamp connections for air quality monitoring and validation activities installed on fascia. As standard, one temperature product probe in chamber is provided for temperature monitoring. Upon request, additional temperature probes are provided.
Autres produits
The AVD Series combines all the features of a Pharma Grade Saturated steam sterilizer with the capability of performing bio-decontamination cycles using VH2O2.
The AMS Series of Pharmaceutical Grade Steam-Air Mixture sterilizers is a range of autoclaves designed for terminal sterilization using steam air mixture technology.
Steelco’s range autoclaves using superheated water are for the terminal sterilization of injectable solutions.
Steelco designs and manufactures a wide range of Class 100 static depyrogenation sterilizers (ISO 14644-1 class 5) to meet the most challenging pharmaceutical requirements.
Sterile continuity is the vision. The SPE Series is ideal for treating closures for containers normally used in the pharmaceutical industry, where continuous sterility has to be maintained between different phases.
The DHP Series of Grade Decontamination air Lock is manufactured to provide a complete turnkey solution for the bio-decontamination of heat-sensitive equipment.
The AGS Series of sterilizers using Ethylene Oxide represents the best relationship between engineering and quality price, operating running costs, and, most important, the safety of the system and operators.