High-Tech Conversions FS-NT203-99-20CB Cobalt Blue® Sterile 70% IPA Nonwoven Polyester Wipes, 9" x 9", 40 Wipes/Bag, 20 Bags/Case
High-Tech Conversions FS-NT203-99-20CB Cobalt Blue® Sterile 70% IPA Wipes — Nonwoven Polyester | 9" × 9" | 40 Wipes/Bag, 20 Bags/Case
The High-Tech Conversions FS-NT203-99-20CB Cobalt Blue® is a validated sterile, gamma-irradiated presaturated cleanroom wipe for pharmaceutical compounding, aseptic processing, and critical contamination control environments. Each wipe is made from Nova-Tech 203™ nonwoven polyester — a hydroentangled, virgin polyester fabric that is extremely clean, soft, abrasion resistant, and virtually free of particle generation. Wipes are presaturated with 70% IPA / 30% DI water filtered to 0.22µ, and converted in a Class 100 (ISO 5) cleanroom. Sterility is validated to a Sterility Assurance Level (SAL) of 10⁻⁶ per ANSI/AAMI/ISO 11137:2013 via Cobalt-60 gamma irradiation. Each case includes a Certificate of Irradiation.
Packed in convenient resealable pouches with four clean-cut edges to eliminate fiber contamination. Each pouch contains 40 wipes; cases contain 20 bags (800 wipes/case).
Specifications
| Part Number | FS-NT203-99-20CB |
|---|---|
| Brand | Cobalt Blue® by High-Tech Conversions |
| Fabric | Nova-Tech 203™ — Nonwoven Polyester (Hydroentangled, Virgin Polyester) |
| Saturation | 70% Isopropyl Alcohol / 30% Deionized Water |
| IPA Filtration | 0.22µ filtered |
| Wipe Size | 9" × 9" (22.9 cm × 22.9 cm) |
| Edge Type | Clean-Cut (4 clean edges) |
| Sterility | Validated Sterile — SAL 10⁻⁶ per ANSI/AAMI/ISO 11137:2013 |
| Sterilization Method | Cobalt-60 Gamma Irradiation |
| Wipes per Bag | 40 |
| Bags per Case | 20 |
| Total per Case | 800 wipes |
| Packaging | Resealable pouches, lot number on each package |
| Documentation | Certificate of Irradiation included with each case |
| ISO Classification | ISO Class 5–8 (Class 100–100,000) |
| Compliance | USP <797>, USP <800> |
| Conversion Cleanroom | Class 100 (ISO 5) |
Key Features
- Validated sterile — SAL 10⁻⁶ — sterilized by Cobalt-60 gamma irradiation per ANSI/AAMI/ISO 11137:2013; required for aseptic processing and pharmaceutical cleanrooms
- 0.22µ filtered IPA — IPA filtered to 0.22 microns before saturation for ultra-low bioburden fluid contact
- Certificate of Irradiation — included with every case for GMP documentation and regulatory compliance
- Lot-numbered packaging — every pouch identified with a lot number for full traceability
- Four clean-cut edges — eliminates fiber shedding at wipe edges; critical for aseptic environments
- Nova-Tech 203™ nonwoven polyester — converted in a Class 100 cleanroom; extremely low particle generation and extractables
- Resealable pouches — easy one-at-a-time dispensing; maintains sterility and saturation between uses
- USP <797> / <800> compliant — meets requirements for pharmaceutical compounding and hazardous drug handling environments
Industries & Applications
- Pharmaceutical compounding — USP <797>/<800> ISO 5 buffer room and ante-area surface disinfection requiring validated sterile wipes
- Aseptic manufacturing — sterile surface wipe-downs in isolators, RABS, and LAF workstations
- Biotech and life sciences — critical cleanroom surface disinfection where sterility documentation is required
- Medical device manufacturing — sterile controlled environment surface prep
- Hospital pharmacy and compounding — sterile IPA wipes for IV preparation areas
- Laboratory and research — ISO 5–8 surface disinfection requiring certified sterile wipes
Frequently Asked Questions
What does "validated sterile" mean for these wipes?
Validated sterile means the wipes have been sterilized using a documented, validated process — in this case Cobalt-60 gamma irradiation — and tested to confirm a Sterility Assurance Level (SAL) of 10⁻⁶, meaning the probability of a non-sterile unit is 1 in 1,000,000. This meets the sterility requirements for USP <797> and aseptic manufacturing environments.
What is the difference between sterile and non-sterile presaturated wipes?
Non-sterile wipes (like the Free-Sat FS-NT1-77) are manufactured in a cleanroom but not sterilized — they are appropriate for ISO 5–8 general surface cleaning and disinfection. Sterile wipes like the FS-NT203-99-20CB have been gamma irradiated to SAL 10⁻⁶ and are required for aseptic processing areas, isolators, and pharmaceutical environments where USP <797>/<800> mandates validated sterile contact surfaces.
Why is the IPA filtered to 0.22µ?
0.22 micron filtration removes bacteria and most particulates from the IPA before saturation, ensuring the fluid itself does not introduce bioburden to the wipe. This is a standard requirement for sterile IPA used in aseptic and pharmaceutical cleanroom applications.
Does every case include a Certificate of Irradiation?
Yes. Every case of FS-NT203-99-20CB includes a Certificate of Irradiation documenting the sterilization process, dose, and lot number — required for GMP documentation and regulatory audits in pharmaceutical and medical device facilities.
Are these wipes compatible with isolators and RABS?
Yes — the FS-NT203-99-20CB is appropriate for use in isolators and restricted access barrier systems (RABS) for pre- and post-cycle surface cleaning. Verify compatibility with your facility’s SOP and validation program before use in critical aseptic processes.
What ISO class are these wipes rated for?
ISO Class 5–8 (Class 100–100,000). They are converted in a Class 100 (ISO 5) cleanroom and validated sterile, making them appropriate for the most critical pharmaceutical and aseptic environments within that range.
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