Hull i-Dositecno Versaline for Ophthalmics

i-Dositecno Ophthalmics

Simplify your ophthalmic manufacturing process with a filling solution that promises the ultimate in accuracy and sterility – the SP i-Dositecno Versaline for ophthalmic applications 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 Versaline for opthalmics 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 compliance 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 Versaline for Opthalmics 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 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 system to meet your exact needs.

Application Examples

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 – 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)