The growing concern for product and operator protection, and the increasingly broad pharmaceutical regulatory framework make it essential to design production equipment in conjunction with its containment system.
In the aseptic pharmaceutical industry, manufacturing must be free of microbial and particle contamination. The environment classification required for aseptic or sterile processing is ISO 5 or class A, which requires:
Particle count (> 0.5 μm) less than 3,520
Suspended units per cubic meter
Laminarity of the flow covering the product
Cleaning and decontamination procedures
This set of standards and requirements have led Dara Pharma to develop a range of products suitable for every need and environment, offering different levels of continuous protection with the following equipment:
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