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 Ophtha-Line™
Simplify your ophthalmic manufacturing process with a filling solution that promises the ultimate in accuracy and sterility – the SP i-Dositecno Ophtha-Line™! Suitable for eye-drops or eye solutions where three-piece container closures are used for different product dosage forms, you can be sure that your ophthalmic products are of the highest quality.
- Innovative, oversized mechanical unscrambler, sorts and feeds plastic containers up to 500 mL
- Fully compliant – 21 CFR Part 11 compliant integrated software and IQ/OQ validation packages available
Overview
With the demand for sterile eye care products growing, never has it been more important to have an ophthalmics filling solution that meets your throughput demands while retaining sterility and accuracy. SP i-Dositecno Ophtha-Line™ offers a choice of machines and dispensing methods for the efficient filling of eye care products into different container closure systems. At SP, we understand that sterility, accuracy, speed and compliancy are key. That’s why we offer high-quality, dependable fill-finish solutions that are easily-integrated and meet the expectations of cGMP, Annex 1 and regulatory agencies such as the FDA.
All SP i-Dositecno Ophtha-Line™ systems include:
- Fill capability for up to 12,000 units per hour
- Built to cGMP and compliant to GAMP5
- Equipped with dedicated hopper to increase automatic container feed
- Servo driven linear transport of containers and filling nozzles
- Able to work with preservative-free standard drop caps
- Available with up to 4-channel pick and place for tips and caps, and with one, two or four filling nozzles
- Filling dose from 0.1 mL to 250 mL
All SP i-Dositecno Ophtha-Line™ systems come complete with Siemens or Allen Bradley PLC-controlled servo motors that allow you to automatically set the output rate, height and water/air flow for each vessel size. With help from our product portfolio experts and dedicated engineers, you can configure the Ophtha-Line™ to meet your exact needs.
Features & Benefits
- Fast turnaround time – enables quick delivery time to shorten time to market
- Flexible – able to handle and fill Aptar or Nemera type containers
- Ultimate sterility – SP i-Dositecno Ophtha-Line™ can be installed in a traditional cleanroom, in restricted access barriers (RABs), or in an isolator
- Robust and resilient change parts made of POMc (Polyoxymethylene Copolymer) guarantee longevity
- SP provides Project Management and optional validation assistance, Installation Qualification (IQ) and Operational Qualification (OQ)
Application Examples
- Eye Drops
- Ophthalmic Eye Care Solutions