WHEATON DUAL. Vial. Perfecting the science of sample protection

Transcription

1 WHEATON Perfecting the science of sample protection

2 WHEATON DualFusion vials combine the best properties of glass, with the mechanical strength and the precision molding of plastic. The vials are engineered to protect pharmaceutical drugs and sample formulations that are prone to cause glass delamination and that are sensitive to oxidation via the permeation of atmospheric oxygen. Using a state-of-the-art Plasma Enhanced Chemical Vapor Deposition (PECVD) Technology, an organosilicate protective layer is fused with a silica-like (SiO2 barrier) layer. These layers are fused to a Cyclic Olefin Polymer (COP) shell to form a robust covalently bonded material. The result is an inert surface that offers unparalleled protection against container leachates and environmental stressors, such as oxygen. Target Applications DualFusion vials do not experience delamination by the mechanism originating from ion exchange reactions or silicon network hydrolysis. While exhibiting low oxygen permeation rates similar to that of glass, these unique properties make DualFusion the vial of choice in the following packaging applications: Biologic drugs such as proteins, peptides, enzymes, DNA and RNA that are sensitive to leachates and oxidizing agents Complex formulations that may interact with glass causing delamination High potency and radioactive substances where container breakage is of great concern Injectables that may react with glass leachates (e.g. Al3+, Ca2+, Fe3+, Fe2+, Na+, Si2+ and Ba2+) Lyophilized products * Laser etched individual 2D barcode and unique identification number for manufacturing traceability

3 WHEATON COP Shell Greater mechanical strength than Type I borosilicate glass allows the vial to withstand higher compression force before breakage Laser etched individual 2D barcode and unique identification number for manufacturing traceability Ability to withstand a wide range of temperatures (-196 C C) PROTECTIVE LAYER (SiO xcyhz) BARRIER LAYER (SiO 2) CYCLIC OLEFIN POLYMER SHELL Barrier to Oxygen & Extractables Fusion 1 (Barrier Layer) A silica-like layer covalently bonded to the COP shell via an adhesion layer by PECVD Technology Blocks oxygen and other gas permeation from the atmosphere to the solution Prevents leachates from the COP shell and from label adhesives Top Surface ph Protection Fusion 2 (Protective Layer) An inert organosilicate protective layer that minimizes drug-container interaction FUSION LAYERS A protective layer against silicon network hydrolysis observed in high ph environments (ph from 3 to 11)

4 Low the ph scale High Protection Zone Type I Glass SiO2 Coating/Quartz Protection against Extractables and Leachables Low ph: Metal Ion Migration Due to Ion Exchange Reaction Metal ions migration from glass to solution occurs in an acidic environment where the (H + or H 3 O + ) from a water molecule is exchanged with an alkali metal ion from the glass matrix. This reaction results in the leaching of several metal ions into the solution and a shift in the solution s ph. DualFusion offers maximum protection against these reactions via the protective and barrier layers that stop ion migration from the solution to the COP shell. Furthermore, the vial composition contains only Silicon (Si), Hydrogen (H), Carbon ( C ) and Oxygen (O 2 ) without the addition of any other metals that may leach into the solution. Below is the extraction profile of DualFusion vs. Type I borosilicate glass vials in an acidic environment. Ion Leachate Aluminum Boron Calcium Iron Type I borosilicate glass vials 450 ppb 580 ppb 290 ppb 50 ppb DualFusion vials Not detected Not detected Not detected Not detected Extraction performed with filled vials (ph 2.5) for 72 hours at 50 C and tested using ICP/OES. Detection limit for Al, B, Ca and Fe 5 ppb. Minimizing the ph Shift in Water for Injection (WFI) Storage The ph shift in WFI storage was evaluated after prolonged storage inside 6mL Type I borosilicate glass vials and 5mL DualFusion vials. s were filled with WFI (buffered to a ph of 5) and stored over a six month period. The ph of WFI in DualFusion vials only increased marginally compared to the shift observed in Type I borosilicate glass vials. WFI ph ph Shift in WFI During a 6 Month Evaluation Period Glass High ph: Metal Ion Migration via Silicon-Oxygen (SiO) Network Hydrolysis The hydrolysis of the SiO network usually occurs in a basic environment where the (OH - ) ion attacks the SiO network in either glass, SiO 2 coated or quartz containers. These reactions result in silicon dissolution as well as other leaching metal ions involved in the formation of the siliconoxygen network. The graph to the right illustrates the silicon dissolution rate for Type I borosilicate glass and DualFusion vials. In this experiment, vials were filled with phosphate buffer Dissoltion Rate (µg Si/day) Silicon Dissolution Rate Comparison (ph 8 phosphate buffer at 40 C) Glass (ph 8.0), a commonly used buffer in storing different biologics substances, and were incubated for one month at 40 C. Silicon dissolution rate was analyzed via ICP/OES analysis.

5 O 2 Permeability at 25 C PPO Protection from Oxygen Permeation Superior Protection against Oxygen Permeation Gas permeation, or gas transmission rate, refers to the rate at which a gas or vapor passes through a polymer. Oxygen permeation presents a real challenge to formulations that are sensitive to oxygen. These formulations may undergo oxidation or other degradation pathways that ultimately reduce drug efficacy during storage. Better barriers Polystyrene Polypropylene HDPE In the graphs below, the oxygen transmission rate (OTR) of the 5mL vials were measured to gauge the combined effect of storage duration and formulation type to mimic a wide range of pharmaceutical formulations. The OTR of DualFusion vials are at least 20 times lower than that of the COP monolayer vials. This proves that even under extreme mechanical stress, DualFusion vials provide an excellent oxygen barrier and offer optimal protection from oxygen permeation OTR of 5mL 25 C PVC OTR (cc O2/container/day) Uncoated COP Glass Better barriers Cyclic Olefins OTR per Day OTR of 5mL vials Containing Different ph Solutions ph 3.5 ph 7.4 ph 8.0 WFI Glass

6 Manufactured in a Class 7 Clean Room Meet USP<788> for low particulate levels and USP<85> for low endotoxin level for injectables Can be sterilized via Gamma Radiation, ETO and E-beam VWR Cat No. Wheaton Cat No. Fill Volume (ml) D x H (mm) Crimp Finish (mm) Qty/Pack Qty/Case W x W W x W *Wheaton offers a variety of best in class rubber stoppers and aluminium seals that are compatible with the DualFusion vials. WHEATON is a registered trademark of WHEATON Industries Inc. Copyright 2017 WHEATON Industries Inc. Printed in USA. VWRBRO_012 03/ Lit. No W