DRUG STABILITY + USABILITY
What if your drug could be contained in a pure glass, hermetically sealed package? And what if that same package had the safety, accuracy, and a convenience of a prefilled syringe? That’s what AFS is all about.
the ampoule-filled syringe (afs)
The AFS combines the superior drug stability of ampoules with the usability of prefilled syringes. The drug-filled ampoule is fully encased within a secondary chamber, and a 5-micron filter eliminates glass particulate from the drug.
aren't ampoules antiquated?
Absolutely – In fact, they’ve been around since the 1800s. And ampoules do have some issues, like injuring operators and leading to glass particulate. But, despite these down sides, there are some good reasons that ampoules have stood the test of time, including the following:
- Intrinsic closure integrity
- Glass inert to most drugs
- Impermeable – air, moisture
- Sterilization compatible
- Durable, tamper-proof
- Transparent for inspection of drug
- Low cost
- Large installed MFG base
BUT WHAT IF AMPOULES HAD THE USABILITY OF PREFILLED SYRINGES?
HOW AFS WORKS
It’s a simple and familiar process to access drug and deliver using the AFS. The 4-step process is outlined by the visuals shown below.
STEP 1 - SNAP
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STEP 2 - DRAW
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STEP 3 - PRIME
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STEP 4 - INJECT
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LEARN MORE
The best way for us to tell you more about Ampulis and the AFS platform is through our email series. If you are interested, please subscribe through the form below. Thanks!
FAQ
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.