Teknipure TS1MPI70-911S TekniPolyPro™ Sterile Presaturated Meltblown Polypropylene Cleanroom Wipers, 70% IPA, 9"x11"
Teknipure TS1MPI70-911S TekniPolyPro™ Sterile Presaturated Meltblown Polypropylene Cleanroom Wipers, 70% IPA, 9"x11"
The Teknipure TS1MPI70-911S TekniPolyPro™ is a sterile presaturated meltblown polypropylene cleanroom wiper pre-wetted with 0.2µm filtered 70% USP-grade IPA and 30% DI water, gamma-irradiated to a sterility assurance level (SAL) of 10⁻⁶ per AAMI guidelines for validated sterility in ISO Class 5–8 environments. Manufactured in an ISO-certified USA facility and lot traceable, these wipers meet stringent GMP, USP <797>, and USP <800> requirements for pharmaceutical compounding, aseptic processing, semiconductor fabrication, and medical device production.
Sold in cases of 1,200 wipers (50 wipers/bag, 24 bags/case). 3-year shelf life from date of manufacture.
Specifications
| SKU | TS1MPI70-911S |
|---|---|
| Material | Meltblown polypropylene |
| Saturation | 70% USP-grade IPA / 30% DI water (0.2µm filtered) |
| Sterility | Gamma-irradiated, SAL 10⁻⁶ per AAMI guidelines |
| Size | 9" x 11" (22.9 cm x 27.9 cm) |
| Cleanroom Rating | ISO Class 5–8 (Grades B–D) |
| Compliance | GMP, USP <797>, USP <800> |
| Packaging | 1,200 wipers/case (50/bag, 24 bags/case) — peel-and-reseal bags |
| Shelf Life | 3 years from date of manufacture |
| Origin | USA (ISO-certified facility) |
Frequently Asked Questions
What does gamma-irradiated to SAL 10⁻⁶ mean for cleanroom wipers?
Gamma irradiation to a sterility assurance level (SAL) of 10⁻⁶ means there is no more than a 1-in-1,000,000 probability of a viable microorganism remaining on the wiper after sterilization — the industry standard for sterile medical and pharmaceutical products per AAMI guidelines. This validated sterility level is required for aseptic processing areas, Grade A/B environments, and USP <797>/<800> compounding pharmacy cleanrooms.
Are the TS1MPI70-911S wipers compliant with USP <797> and USP <800>?
Yes. The TS1MPI70-911S is manufactured in an ISO-certified USA facility, is lot traceable, and meets the sterility and contamination control requirements for USP <797> (sterile compounding) and USP <800> (hazardous drug handling) cleanroom environments. The peel-and-reseal bag packaging helps maintain sterility and IPA saturation between uses.
How does the TS1MPI70-911S differ from the non-sterile TS1MPI70-911?
The TS1MPI70-911S is gamma-irradiated to SAL 10⁻⁶ and packaged in sterile peel-and-reseal bags, making it required for aseptic processing and Grade A/B environments. The non-sterile TS1MPI70-911 is suitable for ISO Class 4–8 cleanrooms that do not require validated sterile wiping. Both use the same meltblown polypropylene material and 70% IPA saturation.
What is the shelf life of the TS1MPI70-911S?
The TS1MPI70-911S has a 3-year shelf life from the date of manufacture. The peel-and-reseal bag packaging helps preserve IPA saturation and sterility integrity throughout the shelf life when stored properly in a cool, dry environment away from direct sunlight.
