Summary of the Available Data for the Sterile Injection Applications Submitted between September 2010 and July 2011
| Submission Date | Dosage Form | Route of Administration | Container Type | Container Volume | Subvisible Particle Limit | Method | ≥10 um Particle Count Average ± SD | ≥25 um Particle Count Average ± SD | Visible Particle Specification | Visible Particle Results (Stability Batches) |
|---|---|---|---|---|---|---|---|---|---|---|
| 9/28/2010 | liposomes | Surgical site injection | Glass vials | 10 mL and 20 mL | 6000/600 per container | <788> | 200.2 ± 105.1 | 8.5 ± 5.7 | “Free of Foreign Matter” | All lots “Free of Foreign Matter” |
| 9/29/2010 | solution | Intramuscular or subcutaneous | Glass cartridge | 0.15 or 0.3 mL | 6000/600 per container | <788> | 1.7 ± 1.2 | 0 ± 0 | “Free of precipitates” | “conforms” |
| 10/5/2010 | Lyophilized powder | Intravenous, intramuscular or sub-cutaneous | Polypropylene vial | 1 mg | 6000/600 per container | <788> | 13.7 ± 11.9 | 0.3 ± 0.6 | “The constituted solution is essentially free from particles of foreign matter that can be observed on visual inspection” USP<1> | “Essentially Free from visible particles” |
| 11/3/2010 | Lyophilized powder | Intravenous infusion | Glass vial | 20 mg or 100 mg | 6000/600 per container | <788> | 64.6 ± 93.4 | 10.4 ± 19.9 | No specification provided | N/A |
| 12/7/2010 | solution | Intravenous | Glass vial | 3000/300 per container | <788> | 130.8 ± 36.4 | 11.5 ± 7.0 | No specification provided | N/A | |
| 1/13/2011 | solution | Intravenous | Non-PVC bags | 100 mL | 6000/600 per container | <788> | 133.3 ± 57.7 | 0 ± 0 | “Free of Visible Particles” USP <1> | “Complies” |
| 1/14/2011 | solution | Intravenous, intramuscular | Glass cartridges | 1 mL | 6000/600 per container | <788> | 121.5 ± 92.6 | 1 ± 1.4 | “Solution must be clear. Solution must not contain one or more particles which are visible.” | “Pass” |
| 1/31/2011 | Solution | Intravenous, intramuscular or sub-cutaneous | Pre-filled plastic syringe | 1–10 mL | 6000/600 per container | <788> | 423 ± 157.9 | 6.8 ± 11.7 | No specification provided | N/A |
| 2/25/2011 | Solution | Subcutaneous | Pre-filled glass syringe | 3 mL | 6000/600 per container | <788> | 153 ± 33.8 | 2.3 ± 2.3 | European Pharmacopeia. 2.9.20 Acceptance Criteria—“Clear” | “No significant change in visible particulate matter” |
| 4/7/2011 | Lyophilized powder | Intravenous, intramuscular or sub-cutaneous | Glass vials | 1 mg | 6000/600 per container | “in-house” | 0 | 25 | “Solution is Clear”, USP | “Reconstituted Solution is Practically Free from Visible Particulate Matter” |
| 4/7/2011 | solution | Intravitreal | Glass vial | 1 mL | 6000/600 per container | <788>, 2.9.29 | 0 ± 0 | 0 ± 0 | Solution must be clear. Solution must not contain one or more particles that are visible upon attentive examination (USP<1> European Pharmacopeia. 2. 2.1. | “Pass” |
| 4/29/11 | solution | Intravenous | Polypropylene vials | 1 mL–20 mL | 6000/600 per container | <788> | 32.1 ± 42.5 | 14.1 ± 24.5 | “Free from Visible Particles” | “complies” |
| 5/23/11 | Solution | Intravenous or subcutaneous | Glass pre-filled syringe or glass vials | 0.5–2 mL | 6000/600 per container | <788> | 234.3 ± 280.9 | 2.7 ± 3.1 | “Free of Visible Particulates” Internal SOP | “Free of Visible Particles” |
| 6/21/11 | solution | Subcutaneous | Pre-filled glass syringe | 1 mL | 6000/600 or 3000/300 if LO method fails | USP <788> | 694.3 ± 342.5 | 3 ± 1.3 | No specification provided | N/A |
| 6/30/11 | solution | Intravenous | Glass vial | 2.5 mL | 6000/600 per container | <788>, (Ph.Eur. 2.9.19) | 47 ± 33.1 | 1 ± 0 | No specification provided | N/A |
| 7/12/11 | liposomes | Intravenous | Glass vial | 5 mL | 6000/600 per container | <788> | 59 ± 26.2 | 1 ± 0 | No specification provided | N/A |
SD = standard deviation.