Small scale borosilicate glass systems for the Pharmaceutical industry
Normag has become through the competence in borosilicate glass 3.3, continuous improvement and close cooperation with the chemical and pharmaceutical industries the leader in the field: from the laboratory to the production scale.
As an example, we developed and improved continuously small-scale units for pharmaceutical industry requirements. To ensure the high-quality requirements in this sector, various organizations such as EMA (European Medicines Agency), FDA (American Food and Drug Administration) and WHO publish GMP (Good Manufacturing Practice) guidelines that all companies are required to follow. To meet GMP standards, equipment has to be resistant to a wide range of chemicals and detergents and the surface finish must be easy to clean.
The main features designed for these GMP applications and in clean rooms with mixing and reaction containers up to 100 liters are:
- vessel in borosilicate glass 3.3 with level marks and fully draining
- bottom outlet with minimized dead space and with minimized residual fluid drops in the vessel after emptying
- bottom outlet valve for high-quality pharma applications, with a considerably reduced number of cleaning cycles required according to the standard control method with riboflavin;
- multiple lip seal operation dry and compliant with pharmaceutical standards;
- enameled impeller agitator for a smooth surface and agitator head without gaps;
- very wide and reliable operating temperature, from -80 ° C to 200 ° C;
- stirrer, motor, flange connections and stainless steel frame, special execution for clean room applications, optional for use in autoclaves;
- Corrosion-resistant tri clamp adapters;
- inert corrosion resistant construction made exclusively with enamel, borosilicate 3.3 and PTFE for contact with the product;
Due to this special combination system, Normag can supply a solution that complies with the GMP standard.
Furthermore, on specific requests, it is possible to guarantee the necessary certifications:
- Machinery Directive / EC conformity
- Pressure device directive 2014/68 EU
- ATEX 2014 / 34EU
- ASME / UL standard
- TA-Luft certificates
- Clean room class D
- Riboflavin test certificate
Our highly experienced team of engineers and technicians can handle the project from the design to installation and work together with the customers to deliver the most effective and complete process solutions.