Preservative Free Droppers

MPS Medical has partnered with NEMERA, one of the world leaders in the design, development and manufacturing of innovative drug delivery devices, as a distributor of Novelia®, a unique, award winning drug delivery system for compounded ophthalmic solutions and suspensions to the compounding pharmacy market.

Features and Benefits

Pureflow® Technology

Pureflow® Technology

With the Pureflow® technology, once a drop is dispensed through the blue tip, the single-way valve at the dropper tip prevents the uptake of air and liquids on the distal side of the bottle. Instead a one-way silicone membrane allows air to permeate back into the bottle, thereby decompressing the bottle. This specific design allows for the reduction of microbial ingress. Through this function it is possible to validate a multi-dose preservative free formulation with the utilization of this bottle.

Pureflow® Technology

Benefits for Patients

Benefits for the Compounding Pharmacy

How it works

Bottle Squeezing

Valve Opening: Drop delivery

Valve Re-closing: Valve re-closes sealing the bottle tight

Air Compensation: Pureflow® technology allows air to diffuse into the bottle

Frequently Asked Questions

There are 3 sizes of nozzle, charted below:
Nozzle Size Fluid Viscosity
10 1 to 10 cP
200 10 to 200 cP
1500 200 to 1500 cP
A quick functional check of your solution can be performed via following test.
  • Adding solution to bottle and closing up with cap
  • Turn upside down periodically and drop out solution, repeat this for a few days.
  • Solution should come out in nice drops
    • If bottle is very hard to squeeze a drop out >> Go-up a size (10 to 200)
    • If the solution streams,, go down a size (200 to 10)
Further testing can be performed in coordination with Nemera and their lab testing services.

We have found through end user trial and error, the best selection for this application is the 200 nozzle.

There are several levels of data packets that can be shared for this product some of which will require an NDA to receive. Below is a description of the packets

Packet Level

Contents

Pack 0

-          Product overview

Pack 1

-          Capping recommendations

-          Functioning & Composition (light)

-          ISO Certificates

-          Product Performance & Microbiological Package (light)

Pack 2 – NDA required

-          Product Composition (detailed)

-          Product Functioning (detailed)

-          Product Performance & Microbiological Package (detailed)

Pack 3 – NDA required

-          Raw Material Compliance

-          Silver Ions Evaluation

 

This product has a special operational set-up at MPS. The purchased part is a ‘kit’ of two separate line items. The bottle is sterilized separately (ETO) from the cap (gamma). Final product is kitted and sold under one line item. Example of this:

Customer Order: PF-P2-1110

Product Shipped: Outer Box Label – PF-P2-1110, Inside Contents: 25 2-Packs PF-N2-10 & 25 2-Packs PF-B2-11.0

A final cert will be provided for item PF-P2-1110

Yes. Products sterilized and released to sterility assurance level (SAL) of 10–6. The caps come sterilized via Gamma sterilization. The bottles are sterilized via ETO.

Every MPS Medical sterilization load is tested for LAL per USP <85> and < 161> and verified to meet the endotoxin limit of ≤0.5EU/mL or ≤20.0 EU/device prior to release and that they are non-pyrogenic.

Have any questions?

Contact our Customer Service team for additional support at (844) 641-3814 or by email at [email protected]

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