Equipment and Materials Used in the Study
| Equipment | Supplier/Model |
|---|---|
| Autoclave | Steris (Mentor, OH)/Amsco Century |
| Balance | Mettler Toledo AG 204 (Columbus, OH)/AG135 |
| Digital thermometer; with Type K thermocouple | John Fluke Mfg., Inc. (Everett, WA)/Fluke 52 |
| Pressure gauge (0 psi–30 psi) with 1-inch sanitary fitting | Anderson (Fultonville, NY)/EB029 |
| Pressure vessel, 5 liter, stainless steel storage tank | Alloy Products Corp. (Waukesha, WI) Custom made |
| Stoppering tool | Becton Dickinson (Frankilin Lake, NJ)/Custom made |
| Materials | |
| 1 mL-long syringe with 26G × ½″ staked needle | Becton Dickinson (Swedesboro, NJ)/1 Ml long |
| Rigid needle shield (RNS) | Helvoet Pharma (Pennsauken, NJ)/FM27 |
| Plunger stopper stopper (Flurotec coated on product-contact surface) | Becton Dickinson (Swedesboro, NJ)/W4023/FLT |
| Helium | Praxair (Danbury, CT), 5.0 Ultra High Purity Grade |
| Nitrogen | Praxair (Danbury, CT), 5.0 Ultra High Purity Grade |
| Vent filter, pore size: 0.2 μm, membrane: PTFE | Pall Corporation (Ann Arbor, MI)/ACRO® 50 |
| Monoclonal antibody formulation (150 mg/mL anti-IgE, 200 mM arginine-HCl, 20 mM histidine/histidine-HCl, 0.04% polysorbate 20, pH 6.0) | Genentech (South San Francisco, CA) |
| Sodium chloride | J. T. Baker (Phillipsburg, NJ) |
| Water, distilled | Genentech (South San Francisco, CA) |