ATS Hull LyoStar 4.0 R&D/Process Development Freeze Dryer
ATS VirTis Ultra 50L & 35L Pilot-Production Freeze Dryers
ATS VirTis Genesis Pilot Freeze Dryer
ATS Hull LyoConstellation S10/S20/S30 Pilot Lyophilizers
ATS VirTis AdVantage Pro Freeze Dryer
ATS VirTis General Purpose Freeze Dryer (GPFD)
ATS VirTis Freezemobile
Research, Developments & Pilot Scale Freeze Dryers/Lyophilizers
Filling/Stoppering/Capping
ATS i-Dositecno Versa-Line Pharmaceutical Filling Equipment
ATS i-Dositecno Micro-Line Vial Filling Lines
ATS i-Dositecno SY Flex-Line Robotic-Syringe Fillers
ATS i-Dositecno RF Flex-Line Robotic-Syringe Fillers
ATS i-Dositecno SY Syringe Filling Equipment
ATS i-Dositecno Ophtha-Line™
ATS i-Dositecno Nasal Spray Filling Machine
ATS Hull BI I/L Filler
ATS i-Dositecno LI-C Linear Capping Machine
ATS i-Dositecno Pharmaceutical Labeling Machine
ATS i-Dositecno Ready-To-Use (RTU) Denesting Equipment
When it comes to your fill-finish workflow, sterility and efficiency are key. Denest and renest with confidence! Our ready-to-use (RTU) denesting equipment is here to help you separate and reassemble your products with ease. Rest assured the SP i-Dositecno Denesting Equipment is robust and efficient, so your sterile, clean, ready to fill (SCF) components are transported smoothly through your fill-finish workflow.
- Cleanroom ready – engineered from premium steel to comply with cleanroom requirements
- Fully compliant – 21 CFR Part 1 integrated software and IQ/OQ validation packages available
Overview
When your products are supplied in nested packaging and filled in pre-sterilized containers, you need a denesting and renesting system that offers accuracy, sterility and speed. The SP i-Dositecno Denesting Equipment includes innovative features such as a Stäubli TX2 robot with CS9 controller to ensure your SCF components are unloaded and reloaded with precision – whether that be syringes, vials or cartridges. And, with the capacity to process up to 2,400 units per hour (uph), there’s a solution for all of your needs.
Built to cGMP and compliant to Annex 1, 21CFR part 11 and GAMP5, our semi-automatic denesting equipment can be assembled in an isolator or restricted access barrier system (RABs) for the ultimate in aseptic processing. And if a full fill-finish line is what you need, the SP i-Dositecno Denesting Equipment is ready-to-use and easily integrated.
SP i-Dositecno’s Denesting Equipment includes Siemens or Allen Bradley PLC-controlled servo motors that allow you to automatically set the rate and height for each vessel. With help from our product portfolio experts and dedicated engineers, you can configure the SP i-Dositecno Denesting/Renesting Equipment to meet your exact needs.
Features & Benefits
- No room for human error! Minimal operator intervention required to move containers from one station to the next
- Fully compliant – designed for high-risk sterile environments GMP Grade A/ISO 5
- Resilient – enclosed arm structure and sealed vertical cable means the SP i-Dositecno Denesting Equipment is built to withstand the hydrogen peroxide (H2O2) decontamination process, with full resistance to vaporous and fluid H2O2
- Compact and versatile – modular and scalable system with small footprint, thanks to integration of motors, enables easy integration into your existing line
- SP provides project management and optional validation assistance, Installation Qualification (IQ) and Operational Qualification (OQ)
- Semi-automatic with servo driven robotic transport of containers
Application Examples
- Human Injectables Products
- Diagnostic & Test Kits
- Intraocular Injectible Products
- Syringes, Cartridges, Vials