SP i-Dositecno Microline Rotary Filler
Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.
These units can be integrated with a vial washer, depyrogenation tunnel, freeze dryer and freeze dryer loading systems, cappers, external vial washers and tray loaders to provide a full line integrated solution.
Our equipment is able to work as per dehydrogenating tunnel or pre-sterilized vials, and suitable to be sterilized inline (with CIP/SIP equipment and H2O2) or by means of autoclave. Offering a complete package of Documentation as per Pharmaceutical cGMP and FDA requirements.
- Filling, stoppering and crimping machine for vials and syringes
- Intermittent rotary filler for doses from 1ml to 500ml for formats up to 80 mm ø in simple configuration
- Maximum output 3.000/ hour. For formats up to 26 mm ø in double configuration. 6.000/ hour
- Totally built in stainless steel AISI 304
- Built as per cGMP, FDA standards
- Machine can be sterilized by H2O2 and without corners
- Machine can hold up to 4 heads. Elements in contact with product AISI 316L
- Compact machine including stopper introduction by means of a servo pick and place; capsule introduction and crimping head by pneumatics
- Star wheel controlled by servo-motor
- Controlled through axes controlling system.
- Nozzles ra<0,5 with special rugosity for injectable products
- No vial, no fill
- DQ documentation
- Vials Filling by means of: Peristaltic pump, Stainless steel Rotary pump, Ceramic Rotary pump, CIP/SIP Rotary pump
- High Containment solution.
- Pharmaceutical Fill-Finish
- Vial Washing - Internal/External
- Vial Stoppering, Capping, Crimping
- Rotary with servo driven movement filling line
- IQ, OQ Documentation.
- Vials reject for no filled vials, no stoppered vials, lower Lyo stoppered vials, and no capsule vials.
- CFR21 compliance
- 100% vials weighing
- Laminar Flow (LF). oRABs, cRABs, Isolator
- Gas Flushing