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MPS TipGuard™ Caps – Protect Critical Space During Ophthalmic Preparation
The MPS TipGuard™ is designed to protect the most critical component space during compounding preparations – the dropper tip. The TipGuard™ caps come pre-assembled with the tip inside the cap. This design completely removes the need for a compounder to ever touch the tip during assembly of dropper bottles during their preparation.
Packaging Configured By and For Compounders
Up to three layers of packaging on specific lines allow compounders to reduce handling and wipe down steps.
TipGuard™ caps are neatly organized in an easy-to-use tray with clear packaging for effortless visual inspection.
Sterilized and Endotoxin Tested for Release
Each lot is released sterile and tested for endotoxin through one of our qualified third-party testing labs.
All lots will be accompanied with a detailed Certificate of Analysis showing the measured cleanliness of the product
Measured Cleanliness USP <788> Particulate Tested
Each lot is measured for particulates via a USP <788> methodology through one of our qualified third-party testing labs as follows:
All lots will be accompanied with a detailed Certificate of Analysis showing the measured cleanliness of the product.
Controlled Tip Dosage
• Each dropper contains a specially engineered dropper tip for an accurate and repeatable dosage
• Tip will only dispense a drop when the bottle is squeezed
• Once the bottle is squeezed the tip will form a consistent drop size
Robust Documentation for your Quality Records
Every Lot Release is accompanied by a detailed Certificate of Analysis which includes certifications and measurements of:
- Sterility
- Endotoxin
- USP <788> level particulates
If you need something above and beyond what are documentation has to offer, we can work with you to get it.
Supply Agreement Options
Having steady and reliable ophthalmic dropper supply is critical to your pharmacy operations. Being out of bottles can lead to pharmacy operations coming to a halt.
MPS can work with your team to set-up an on-going supply agreement in a number of way including scheduled deliveries or dedicated supply. Contact MPS today for options
Product Offerings
Customizable OptiDropperTM
Ophthalmic Dropper Bottles
Select a Bottle
Part Number
EA Per Box
Total EA
Unit Price
Price
Select a Tip or Tip/Cap
Part Number
EA Per Box
Total EA
Unit Price
Price
Select a Cap
Part Number
EA Per Box
Total EA
Unit Price
Price
Frequently Asked Questions
What final release testing is performed for these bottle products?
| Test | Method | Component |
| Sterility | Direct Transfer Method Embedded Spore Strip accredited to the ISO 17025 | Bottle, Tip, Cap |
| Endotoxin/LAL | ISO 17025 – (USP), General Chapter <85>, (USP), General Chapter <161>, Medical Devices | Bottle, Tip, Cap |
| USP <788> Test Method 1 – Particulates | Test Method Acceptance Criteria: Based on the methodology of USP <788> | Bottle, Tip (Testing limited to fluid contact surfaces) |
All testing is performed by qualified third party testing labs contracted with MPS Pharma. The final measurements are all reported on our current Certificate of Analysis.
Why do you measure particulates to USP <788>?
USP <771> Ophthalmic Products – Quality Tests:
“Two general categories apply for product administration to the tissues in the eye. Intraocular administration includes all ophthalmic products that cross (penetrate) boundary tissue, such as the cornea and sclera. For subvisible content, USP guidance is followed. Products for intraocular use must comply with Particulate Matter in Ophthalmic Solutions <789>. Product for extraocular use must comply with Particulate Matter in Injections <788>.”
Both USP <788> and <789> are applicable to finished drug products; containers are not considered finished drug product. The testing MPS Pharma has performed on the bottles is based on the methodology of USP <788>, with particulate measurements reported for 10 um and 25 um sizes against limits reported on a per container basis.
Can I see a sample Certificate of Analysis that comes with this product?
See the attached PDF for a sample Certificate of Analysis
I have a special requirement (new pack size, special drop size, etc). Can you help?
Are the parts interchangeable? How does the numbering system work on these parts?
All items with a UA8-425 pre-fix are compatible with each other.
All items with a UA15-415 pre-fix are compatible with each other.
UA8-425 & UA15-415 items are not compatible with each other.
If I open the pouch, will the bottle contents still be sterile?
What is the drop size for these bottles?
A general water reference point can be provided to our customers as a starting guideline:
| Size(s) | Drop Size |
| 3 mL | 42 ul +/- 5 uL |
| 7, 10, 15, 30 mL | 40 ul +/- 5 uL |
What are the bottles made of? Can more information be shared?
A more detailed material profile is available to share with customers who complete a non-disclosure agreement.
Are dimensional drawings of the bottle available?
Do you carry bottles that offer UV protection? Is there data available to share?
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.
Can I get a specification sheet of this item for my records?
See the attached document for the specification sheet
Our pharmacy follows USP <797> and it requires we use depyrogenated materials. Are your products depyrogenated? Do you have a Certificate of Analysis (C of A) stating such?
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.
Have any questions?
Contact our Customer Service team for additional support at
(844) 641-3814 or by email at [email protected]