Our Products
Ampulis Pristal™ — for Lyophilized Formulations
Rethinking Reconstitution
Our Pristal™ platform contains lyophilized formulation and diluent in the same delivery device. Pulling upward on the plunger rod combines components for the reconstitution process. Then, depressing the plunger dispenses the drug. Reconstitution has never been simpler or safer.
Ampulis Flowen™ — for Liquid Formulations
PFS with a Twist
Our Flowen™ platform contains liquid formulations in all-glass, hermetically-sealed ampules. With intrinsic container closure integrity (CCI), this solution provides ideal containment for sensitive formulations while providing the safety and usability of a prefilled syringe. A simple twist accesses the drug, and an integrated filter ensures that particulate is fully removed.
How Flowen™ Works:
Simple. Fast. Familiar.
Accessing and delivering the drug with Flowen™ is straightforward and quick. Here’s how:
STEP 1
STEP 2
STEP 3
STEP 4
STEP 5
Deliver Drug
Make AFS Unique to your Drug
MULTIPLE SIZES
Adapt AFS to your Dose Volume
1.0 mL
2.25 mL
3.0 mL
Frequently Asked Questions
What are the range of dose volumes?
The AFS is capable of accommodating dose volumes from 0.5ml to 12ml. It can be customized to meet the unique needs of your drug.
How much does AFS cost?
The cost structure of AFS is on par with prefilled syringes. The specifics of cost depend on production quantities and design attributes for your application.
Can AFS be used with biologics?
AFS can be used with some biologics. However, drug viscosities and other properties may be limiting factors. The process starts with a feasibility assessment, during which we can provide specific guidance for your unique application.
Can AFS be used for reconstitution?
Yes, AFS can be used with lyopholized drug and diluent, each stored in separate compartments.
How does AFS deal with glass particulate?
Each AFS device contains a filter that eliminates glass particulate from entering the drug.
What needle / tip options are available?
AFS can be configured with a luer fitting compliant with ISO 80369-7, a staked needle, or topical dispensing tip. AFS can also be integrated with a 1-handed needle safety device for compliance with OSHA 1910.1030.
Ampulis Drug Delivery Device
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