See the following attached PDFs:

• A sample nozzle Certificate of Analysis
• A sample bottle Certificate of Analysis

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

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.

We are currently carrying out this product in 1, 2 and 100 pack sizes. We try to provide stock sizes for small and large batch compounders. We have the capability to provide special packaging configurations for our customers. Reach out today to begin collaborating.

The bottle has undergone performance tests of the closure system demonstrating that the bottle can maintain sterile contents over three months of treatment. The test conditions of the study had represented a sever misuse of the bottle over that three-month period.

It is however the responsibility of the compounder to validate that the bottle and in combination with their specific drug are able perform as reflected in the study.

Once the pouch has been opened, then by the definition the parts cannot be considered sterile, unless the pouch is opened in a controlled sterile environment.

Drop size is dependent on several factors including the product being dispensed and the technique in which it is dispensed. The best advice for customers is to test the dropper tip with the compounded product to determine its suitability in its application.

Different nozzle sizes are available that determine the nominal drop size. MPS Pharma always carries a standard size 2.4 mm in stock. The 2.4 mm tends to cover most compounding usage cases. Other sizes are available via a special-order request.

A general water reference point can be provided to our customers as a starting guideline:

The bottle itself is composed of LDPE. The cap/nozzle portion is a multi-component system composed of HDPE and silicone rubber.

A more detailed material profile is available to share with customers who complete a non-disclosure agreement.

Below is a diagram available to share (click on image below for higher resolution):

MPS carries a series of white bottles and nozzles that can be used to create a container closure system that protects a solution from UV light.

Specific testing standards surrounding UV protection of solutions are always performed using the container closure system itself plus the drug contents. MPS does not provide drug with the bottle, therefore no meaningful data can be provided that our end user pharmacies may leverage for their own purposes.

We can anecdotally report however that our customers do routinely use specific products of ours for light protected solutions. Those same customers do report the bottle, in combination with their drug product, pass the UV protection requirement as defined in the existing testing standards.

Please reach out to us to find out which items would work best in supporting a successful passage of these tests.

All MPS lots are tested for endotoxins (pyrogens) and will meet the materials requirements as defined in USP <797>. A detailed explanation of this can be found in this PDF link. All MPS C of As include measurements for these endotoxins.