Hybrid Blood Collection Tubes: Combining the Best Attributes of Glass and Plastic for Safety and Shelf life.

SiO2 Medical Products, Inc. developed hybrid blood collection tubes (BCTs) that combine the breakage resistance of plastic and a shelf life approaching that of glass. These blended attributes provide improved BCT safety and reliability for patients and clinical workers. A shelf life of at least 2 y with less than 10% draw volume variation was demonstrated on evacuated hybrid BCTs, which is approximately 7 times longer than standard polyethylene terephthalate (PET) BCTs. This translates into more consistent and reliable blood draw volumes over a longer shelf life. The moisture vapor barrier of hybrid BCTs is 5 times lower than that of PET BCTs, which significantly reduces preservative evaporation over their shelf life. As a result, the risk of preservative gelation and alteration to the blood-to-preservative ratio mix is practically eliminated. Cyclic olefin polymer (COP) exhibits superior impact resistance to breakage because of its high ductility and impact strength and is not influenced by defects and flaws as is glass. Although COP has a mechanical toughness comparable with that of PET, it maintains this over a wider range of temperatures (-70 to 121 °C). As a result, COP can tolerate steam sterilization and cold storage temperatures without mechanical fatigue, deformation, or breakage. Lastly, extreme centrifugation of water-filled BCTs did not impose breakage of any kind.

Enhanced recovery of low concentration protein and peptide solutions on ultra-low binding microplates.

SiO2 Medical Products (SIO) developed PureWARE™ Ultra-Low Binding (ULB) plasma-treated microplates with the combined benefits of enhanced protein recovery and reduced extractables. This study demonstrates enhanced protein recoveries, but at ten-times lower protein concentration, or 0.1 nM, compared with a prior study. In addition, no significant effect on enhanced protein recovery of plasma-treated microplates was observed in a long-term stability study carried out for 26 months under ambient storage conditions. Furthermore, recovery of three different peptide solutions, in the concentration range of 1.5-12 nM, was also shown to be enhanced on plasma-treated microplates relative to standard polypropylene microplates.

Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials.

For many years, glass has been the default material for parenteral packaging, but the development of advanced plastics such as cyclic olefin polymers and the rapidly increasing importance of biologic drugs have provided new choices, as well as more stringent performance requirements. In particular, many biologics must be stored at non-neutral pH, where glass is susceptible to hydrolysis, metal extraction, and delamination. Plastic containers are not susceptible to these problems, but suffer from higher gas permeability and a propensity for sterilization-induced radical generation, heightening the risk of oxidative damage to sensitive drugs. This study evaluates the properties of a hybrid material, SiOPlas™, in which an ultrathin multilayer coating is applied to the interior of cyclic olefin polymer containers via plasma-enhanced chemical vapor deposition. Our results show that the coating decreases oxygen permeation through the vial walls 33-fold compared to uncoated cyclic olefin polymers, which should allow for improved control of oxygen levels in sensitive formulations. We also measured degradation of two biologic drugs that are known to be sensitive to oxidation, teriparatide and erythropoietin, in gamma and electron beam sterilized SiOPlas™, glass, and uncoated cyclic olefin polymer vials. In both cases, solutions stored in SiOPlas™ vials did not show elevated susceptibility to oxidation compared to either glass or unsterilized controls. Taken together, these results suggest that hybrid materials such as SiOPlas™ are attractive choices for storing high-value biologic drugs.LAY ABSTRACT: One of the most important functions of parenteral drug containers is safeguarding their contents from damage, either chemical or physical. Glass has been the container material of choice for many years, but concerns over breakage and vulnerability to chemical attack at non-neutral pH have spurred the rise of advanced plastics as alternatives. Plastics solve many problems associated with glass but introduce several of their own, including increased gas permeation and generation of oxidizing radicals during sterilization. In this article, we evaluate SiOPlas™, a hybrid material consisting of plastic with a thin multilayer coating applied to the interior, for its ability to overcome these two problems. We find that SiOPlas™ is much less permeable to oxygen than uncoated plastic, and that two biologic drugs stored in gamma and electron beam sterilized SiOPlas™ vials do not display elevated levels of oxidation compared to either glass or unsterilized vials. This suggests that hybrid materials such as SiOPlas™ can exhibit the best qualities of both glass and plastic, making them attractive materials for storing high-value parenteral drugs.

Plasma-Treated Microplates with Enhanced Protein Recoveries and Minimized Extractables.

SiO2 Medical Products, Inc. (SiO) has developed a proprietary technology that greatly enhances protein recoveries and reduces extractables from commercial microplates used for bioanalytical assays and storage of biologics. SiO technology is based on plasma treatment that chemically modifies the surface of polypropylene with predominantly hydrogen-bond-acceptor uncharged polar groups. The resultant surface resists nonspecific protein adsorption over a wide range of protein concentrations, thereby eliminating the need to passivate (and hence potentially contaminate) the microplates with blocking proteins. High shelf-life stability and cleanliness of the plasma-treated microplates have been demonstrated using five different proteins for two common microplate formats. The protein recovery performance of plasma-treated microplates is found to be higher compared with commercial low-protein-binding microplates.