The sterile injectables market is a very demanding. The equipment developed by SP i-Dositecno for this market offers a high quality solution with processing speed capabilities of up to 9,000 u/h (units per hour). In this product range we can offer maximum benefits including isolators for high containment requirements, oRAB’s and cRAB’s, IPC control with check weighing, CFR 21 part 11 compliance and smooth, accurate production.
The SY Series, MI-I Series and BI-I Series systems are able to work with dehydrogenating tunnels or pre-sterilized vials, and are suitable to be sterilised inline (with CIP/SIP equipment and H2O2) or by means of autoclave. Included is a package of Pharmaceutical cGMP and FDA compliant documentation.