Parenteral administration is one of the most popular drug delivery systems as it results in a faster onset of action and also 100% bioavailability. There are several drawbacks, however, with this method including accuracy, sterility, lack of convenience, and not in the least a complete dependence on medical professionals that make it less than ideal. Every single one of these concerns can be quickly addressed through prefilled syringes.
A prefilled syringe is a disposable, single-dose medicine delivery system to which the manufacturer has already prefixed a needle. By their very nature, prefilled syringes cannot be reused. They are not only easy to use, but also uphold the strength, quality, purity or potency of the drug over its shelf life. Medicine stored inside a prefilled syringe cartridge stays sterile for approximately two to three years.
The advantages of this system for mass delivery of vaccines cannot be overstated. With standard vaccine delivery systems, several complications can arise from incorrect dosage or even incompetence of the person administering the medicine. In times of an epidemic or mass vaccinations, the administrators of the vaccine at the ground level are not necessarily medical professionals. This method of drug delivery allows for the inclusion of volunteers with minimal training to support these vaccination drives.
With the drug delivery mechanism is getting increasingly sophisticated and a growing number of compounds in new therapeutic classes, the number of injectable products available is increasing. Drug categories include vaccines, blood stimulants, therapeutic proteins, among others. Many new products, especially expensive biopharmaceuticals that must be injected should be prefilled, with security being the main reason why.
Prefilled syringes eliminate several administrative steps required before a drug in a vial is used. They also help reduce dosing errors as they contain the precise dose needed. They also reduce the potential for contamination and needlestick injuries. They also eliminate wastage – pharmaceutical companies generally overfill vials by about 25% to ensure that the administrator of the dose is guaranteed to withdraw the necessary dose. Overfill, however, can also lead to errors which are eliminated with prefilled syringes. Less waste is always a good thing, especially with vaccines that are expensive or in short supply.
In addition to active ingredients, granules for oral solutions or suspension also contain colourants, flavourings and other ingredients, so the end solution or suspension has all the necessary features of a liquid formulation.
Finally, prefilled syringes can increase the attractiveness of a product to out-licensing partners and improve clinical trial validity and appeal.
While prefilled syringes have been around for more than 20 years, their penetration globally hasn’t been of the same scale as the sophisticated European and American markets. There is tremendous opportunity for pharmaceutical manufacturers in the subcontinent to grow their business by entering into the single dose medication space. And Fabtech can help you realise your goals.
Fabtech’s FabFill prefilled syringe machine has been designed and built to conform to GMP standards. It meets the most stringent quality requirements of the pharmaceutical industry in a wide range of formats and will meet the varied needs of every customer. It comprises of
1. Robotic Tyvek Removal System
- Automatically opens tub barrels and peels them off
- A de-lidding and de-lining machine to open sterile tubes
- An infeed conveyor
- A waste receptacle
- A lid removal station
The system allows for the gentle transfer of the pen tub to the filling machine and can be enclosed in ORABS/CRABS/Isolator as per product requirement
2. Syringe Filling and Closing Machine
This machine is a fully Automatic filling and closing machine to process disposable, nested syringes. It is designed in a modular system and prepared for max 5 pumps output from 6000/hr (2 land) up to 8500/hr (5 land). It has a compact, superior construction and the highest dosing accuracy that also assures sterility throughout the entire process. Size changeovers are easy to execute and settings for dosing volume, filling needle movement and stopper position are easily reproducible. It is a time pressure filling system with peristaltic pumps. This machine is available in manual, semi-automatic and fully automatic infeed system.
- Syringes size: 0.5 – 50 ml nested syringes
- Infeed: X-Y table
- Dosing volume: 0.1- 50ml depending on selected pump size
- Dosing system: Rotary piston pumps
- Filling heads: 1-10ml
- Output: 6000 syringes/hr
- Capacity: 120 tub/hr
3. Syringe Packaging System
This system consists of
A. Automatic Syringe de-nester for removing syringes from the nest
- 1 land infeed chute for approximately 1 nest
- Intermittent nest transport
- Pneumatic controlled vertical and horizontal shaft for removing syringes
- Syringe pick up rail for one complete row of syringes
- Discharge chute for empty nests
- Infinitely adjustable speed
B. Fully Automatic Rotary Plunger Rod inserting machine
This system has a plunger rod insertion module (single-lane version), with plunger rod infeed, pick up and swivelling unit, gripper movement unit, vibratory sorting bowl, 550mm for plunger rods.
- Inclined infeed chute for plunger rods with min/ max, accumulation SENSOR
- Plunger rod inserting plungers
- Syringe rotation drive with slip clutch, speed and torque allow fine adjustment.
- Finished in stainless steel
- Syringe size: 1 – 10ml
- Plunger rod: 1 – 10ml
- Backstop: 1 – 5 ml
- Capacity: 3500 syringes/hr
- All safety interlocking and sensors as per GMP and FDA requirement.
- CE compliant.
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