Teknipure TC2P12S TekniClean® Sterile Polyester Knit Wiper with Sealed Edge, 12"x 12"
Teknipure TC2P12S TekniClean® Sterile Polyester Knit Wiper, Sealed Edge, 12 in x 12 in, Case of 500
The Teknipure TC2P12S TekniClean® Sterile is a gamma-irradiated sterile 100% polyester knit cleanroom wiper with a sealed edge in the 12"x12" format, rated for ISO Class 2–7 environments. Gamma-irradiated to a sterility assurance level (SAL) of 10⁻⁶ per AAMI guidelines, the TC2P12S is designed for aseptic processing areas, sterile manufacturing zones, and any application where a validated sterility assurance level is required. The 12"x12" format provides greater surface coverage per wipe than the 9"x9" (TC2P99S), making it preferred for larger surface areas in sterile environments — biosafety cabinet interiors, isolator surfaces, and large equipment wipedowns in Grade A/B zones. Lot traceable, manufactured in ISO-certified facilities. 3-year shelf life from date of manufacture.
Sold in cases of 500 wipers (25 wipers/bag, 4 bags/pack, 5 packs/case).
Specifications
| SKU | TC2P12S |
|---|---|
| Brand | Teknipure |
| Product Line | TekniClean® Sterile |
| Construction | 100% polyester knit, continuous-filament |
| Edge Treatment | Sealed edge |
| Sterilization Method | Gamma irradiation, SAL 10⁻⁶ per AAMI guidelines |
| Size | 12 in x 12 in (30.5 cm x 30.5 cm) |
| Packaging | 25 wipers/bag, 4 bags/pack, 5 packs/case, 500 wipers/case |
| Cleanroom Rating | ISO Class 2–7 (Grades A–D, Class <1–10,000) |
| Shelf Life | 3 years from date of manufacture (sterile) |
| Traceability | Lot traceable, ISO-certified manufacturing |
| Chemical Compatibility | IPA, disinfectants, solvents, lubricants, adhesives |
| Application | Aseptic processing, biosafety cabinet interiors, isolator surfaces, Grade A/B large surface wipedowns |
| Industries | Pharmaceutical (aseptic fill/finish), medical device sterile assembly, biotech, compounding pharmacy (USP <797>/<800>) |
Frequently Asked Questions
When should I use the 12"x12" sterile wiper vs. the 9"x9" (TC2P99S)?
Both are the same gamma-irradiated TekniClean® Sterile wiper with identical SAL 10⁻⁶ sterilization and ISO Class 2–7 rating. The 12"x12" provides greater surface coverage per wipe, making it more efficient for larger surfaces in sterile environments — biosafety cabinet interiors, isolator surfaces, large equipment exteriors in Grade A/B zones, and pass-through chamber walls. The 9"x9" is better suited for component-level cleaning and smaller surface areas. Most aseptic facilities stock both sizes for different tasks.
What sterilization method is used and what SAL does it achieve?
The TC2P12S is sterilized by gamma irradiation to a sterility assurance level (SAL) of 10⁻⁶ per AAMI guidelines — the industry standard for sterile cleanroom consumables. Gamma irradiation penetrates the sealed packaging to sterilize the wiper without leaving chemical residues. Certificate of irradiation documentation is available for validation files upon request.
When do I need a sterile wiper vs. a non-sterile wiper?
Sterile wipers are required in aseptic processing areas (ISO Grade A/B, ISO Class 4–5) where any non-sterile item introduced into the environment could compromise product sterility — such as sterile fill/finish operations, sterile compounding (USP <797>), and sterile medical device assembly. Non-sterile wipers are appropriate for ISO Class 5–7 environments where bioburden control is important but validated sterility is not required. Always consult your facility’s contamination control strategy (CCS) to determine whether sterile wipers are mandated for your specific zone.
Is the TC2P12S lot traceable for validation documentation?
Yes. TekniClean® Sterile wipers are manufactured in ISO-certified facilities and are lot traceable, supporting validation documentation requirements for pharmaceutical, medical device, and compounding pharmacy cleanrooms. Lot numbers and certificate of irradiation documentation are available to support your cleaning validation files.
