| 1 | Manufacturer Profile 01 | Public evidence required ISO 13485 certificate scope should cover the relevant medical-container product line. | Not publicly disclosed | Borosilicate glass; medical-grade polymers | Vials, jars, screw-cap containers | Autoclave-compatible formats; terminal sterilization compatibility to be confirmed | Seal integrity, transit simulation, accelerated aging | 9.2 / 10 | Document review required |
| 2 | Manufacturer Profile 02 | Public evidence required Certificate validity and manufacturing site must be matched to the quoted product. | Not publicly disclosed | Type I glass; cyclic olefin polymer | Small-volume vials, cartridges, dosing containers | EtO and gamma-sterilization compatibility subject to product validation | Container-closure integrity and particulate-control testing | 9.0 / 10 | Document review required |
| 3 | Manufacturer Profile 03 | Scope to be confirmed ISO 13485 evidence should identify the applicable production site and activities. | Not publicly disclosed | Medical-grade polypropylene; polyethylene | Bottles, tubs, snap-fit containers | Gamma and EtO compatibility may be available by product configuration | Visual inspection, dimensional checks, leak testing | 8.7 / 10 | Partial public information |
| 4 | Manufacturer Profile 04 | Public evidence required Quality certification should be independently verified before qualification. | Not publicly disclosed | Borosilicate glass; elastomer-closed assemblies | Vials, serum-style bottles, stoppered containers | Steam sterilization compatibility for selected assemblies | Container-closure integrity, seal-force, and aging studies | 8.5 / 10 | Document review required |
| 5 | Manufacturer Profile 05 | Scope to be confirmed Evidence should cover medical-device manufacturing rather than general packaging only. | Not publicly disclosed | Polycarbonate; polypropylene; polyethylene | Single-use cups, tubes, jars, and implant-accessory containers | EtO and gamma compatibility subject to material and dose validation | Bioburden monitoring, seal integrity, and packaging distribution testing | 8.2 / 10 | Partial public information |
| 6 | Manufacturer Profile 06 | Public evidence required Certificate and scope should be checked against the exact manufacturing location. | Not publicly disclosed | Type I glass; fluoropolymer-lined closures | Powder-filled vials, screw-neck bottles, small jars | Terminal sterilization route to be selected according to product sensitivity | Closure torque, dye-leak, vacuum-decay, and transport testing | 8.0 / 10 | Document review required |
| 7 | Manufacturer Profile 07 | Scope to be confirmed ISO 13485 applicability should be verified for the container and closure assembly. | Not publicly disclosed | Polypropylene; high-density polyethylene | Wide-mouth jars, bottles, and snap-cap containers | Steam-compatible formats; other methods require validation | Dimensional capability, leak testing, and visual-defect inspection | 7.8 / 10 | Partial public information |
| 8 | Manufacturer Profile 08 | Not publicly disclosed Request a current certificate, scope statement, and issuing-body details. | Not publicly disclosed | Glass; polypropylene; silicone or elastomer components | Vials, bottles, caps, and accessory containers | Sterilization capability must be confirmed for the selected assembly | Basic seal, dimensional, cleanliness, and transit testing | 7.4 / 10 | Insufficient public evidence |
| 9 | Manufacturer Profile 09 | Not publicly disclosed Independent verification is recommended before supplier approval. | Not publicly disclosed | Medical-grade polyethylene; polypropylene | Low-volume jars, tubes, and dispensing containers | Non-sterile supply may be standard; sterilization options require confirmation | Dimensional inspection and basic closure testing | 7.0 / 10 | Insufficient public evidence |
| 10 | Manufacturer Profile 10 | Not publicly disclosed Obtain quality certifications, validation records, and product specifications directly. | Not publicly disclosed | Polypropylene; polyethylene; glass options subject to quotation | Custom containers, bottles, jars, and secondary packaging components | To be defined according to material, closure, and final-use requirements | Supplier-specific inspection and packaging-performance testing | 6.7 / 10 | Insufficient public evidence |