High Recovery Vials Reduce Residual Product Waste by 99%
A Cost-Effective Alternative for Pharmaceutical Product Packaging
For primary packaging, particularly of high-value products including biologics and some vaccines, a high recovery vial such as the NextGen™ V-Vial®; provides long-term savings for pharmaceutical manufacturers.
Pharmaceutical companies manufacturing billions of liquid doses each year risk significant product waste when using flat-bottom vials for end user packaging. According to the U.S. Pharmacopoeia (USP), “each container of an injection contains sufficient excess” of the labeled dose or size to allow withdrawal of the labeled quantity of drug.1 High Recovery Vials (HRVs) that feature conical shaped bottoms significantly reduce residual waste by enabling maximum product retrieval without the need to overfill.
DWK Life Sciences, a leading provider of laboratory glass and plastic consumables for life science and biopharmaceuticals, including HRVs, conducted a study that examined residual waste in HRVs and flat-bottom vials.
DWK compared a standard 2mL flat-bottom vial, a 2mL WHEATON® E-Z Ex-Traction® Vial, and a 2mL WHEATON® NextGen™ V-Vial®.
A balance was turned on with draft shields closed, allowed to equilibrate and tared to zero. The empty, dry vial was placed on the balance, and the mass was recorded (MD). The vial was removed from the balance, and 1.50mL of distilled water was added using a manual pipette. The filled vial was then returned to the balance where its mass was recorded (MF). The filled vial was removed from the balance and set on a flat surface. Using the manual pipette, as much distilled water as possible was retrieved from the vial. Finally, the mass of the emptied vial was measured and recorded (ME). Twenty-five individual vials were measured and recorded for each vial type.
From these collected data, both the volume of liquid in the vial, or filled volume (VF) and the residual volume (VR) of liquid left in the vial were calculated. Subsequently, the percent waste (PW) and percent decrease (PD) were determined.
To measure residual waste, DWK used these conversion factors and formulas:
1g dH2O = 1mL dH2O at STP
MD in grams Mass of dry vial
MF in grams Mass of filled vial
ME in grams Mass of emptied vial
Filled Volume (VF): VF = (MF – MD ) × (1mL H2O/1 g H2O)
Residual Volume (VR): VR = (ME – MD ) × (1mL H2O/1 g H2O)
Percent Waste (PW): PW = (VR / VF ) × 100
Percent Decrease (PD) in Liquid Remaining in EZ Ex-Traction (Z) or NextGen V-Vial (V) vs. Standard Flat-Bottom Vial (S):
PD = ((VRS – VR [Z or V]) / VRS) × 100
The E-Z Ex-Traction and NextGen V-Vials both significantly decrease product waste. The E-Z Ex-Traction Vial offers a 97.7% decrease in wasted residual product, while the NextGen V-Vial offers a reduction of 99.1%.
Applying the sample data to a theoretical 50L batch size, the standard flat-bottom vials generated the most product waste with 7.8% of the product remaining in the vial. The E-Z Ex-Traction Vial produced a significant reduction in waste with only 0.2% of the residual product remaining and the NextGen V-Vial further reduced waste to 0.1%. This reduced waste results in 2350 more fills with the E-Z Ex-Traction Vial and 2383 more fills with the NextGen V-Vial compared to a flat-bottom vial. For primary packaging, particularly of high-value products including biologics and some vaccines, a high recovery vial such as the NextGen V-Vial provides long-term savings for pharmaceutical manufacturers. Return on investment in HRVs stems from greater product recovery without the need to overfill for complete retrieval. The USP recommends that pharmaceutical manufacturers overfill vials as much as 24 percent “to permit withdrawal and administration of the labeled volumes.”2 Using HRVs lets pharmaceutical manufacturers fill considerably more vials with the same batch volume, ultimately reducing manufacturing costs. In addition, HRVs eliminate the possibility of end users pooling” residual volumes from individual vials to create additional dosages.
In addition, HRVs eliminate the possibility of end users “pooling” residual volumes from individual vials to create additional dosages.
1 USP <1> Injections
2 USP <1151> Pharmaceutical Dosage Forms
Sign up for the GSS Resources Newsletter, an eNewsletter that delivers new technology and news, straight to your inbox.
ISO 9001:2015 Certified
Copyright 2020, Government Scientific Source. All Rights Reserved.