SP 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
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:
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.
- 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
- Eye Drops
- Ophthalmic Eye Care Solutions
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)