Vileda Professional 147546 | CE Roll-O-Matic Sterile Cleanroom Mop Refill | 10 inch Stainless Steel | 12/cs
Vileda Professional 147546 | CE Roll-O-Matic Sterile Cleanroom Mop Refill | 10 inch Stainless Steel | 12/cs
The Vileda Professional 147546 is a 10-inch sterile CE (Controlled Environment) Roll-O-Matic® sponge mop refill with a stainless steel channel. Manufactured and sterilized in the USA, validated to a Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 11137. Each refill is individually double-bagged with a lot number and sterility indicator dot on each package. Certificate of Sterility available with each shipment upon request. Designed for aseptic manufacturing, Grade A/B cleanrooms, pharmaceutical fill-finish, and any application requiring documented sterility validation.
For the non-sterile version, see 119658. For the 14-inch sterile version, see 147548. Compatible with all 10” Roll-O-Matic® handles.
Key Specifications
| Specification | Value |
|---|---|
| Part Number / SKU | 147546 |
| Size | 10 inch |
| Channel Material | Stainless steel |
| Color | Blue |
| Sterility | Sterile — validated to 10⁻⁶ SAL per ISO 11137 |
| Packaging | Case of 12, individually double-bagged |
| Lot Control | Yes — lot number and sterility indicator dot on each package |
| Certificate of Sterility | Available with each shipment upon request |
| Manufactured & Sterilized | USA |
| Autoclavable | Yes |
| Gamma/ETO Resistant | Yes |
| Foam | Advanced Technology foam — 25% more absorption, 2× liquid release vs. competing foams |
| Handle Compatibility | All 10” Roll-O-Matic® handles |
| Brand | Vileda Professional |
CE ROM Refill Family — Full SKU Reference
| Description | Channel | Size | Sterility | Art. No. | Case Qty |
|---|---|---|---|---|---|
| CE ROM Sponge Refill | Galvanized | 10 in | Non-Sterile | 119659 | 12 |
| CE ROM Sponge Refill | Galvanized | 14 in | Non-Sterile | 119655 | 12 |
| CE ROM Sponge Refill | Stainless Steel | 10 in | Non-Sterile | 119658 | 12 |
| CE ROM Sponge Refill | Stainless Steel | 14 in | Non-Sterile | 119654 | 12 |
| CE ROM Sponge Refill | Stainless Steel | 10 in | Sterile | 147546 | 12 |
| CE ROM Sponge Refill | Stainless Steel | 14 in | Sterile | 147548 | 12 |
Key Features
- Validated sterility — 10⁻⁶ SAL per ISO 11137 — sterility validated to the international standard for sterilization of medical products; suitable for aseptic manufacturing and Grade A/B environments
- Individually double-bagged with indicator dot — each refill is double-bagged with a sterility indicator dot on the outer package, allowing visual confirmation of sterile status before opening
- Certificate of Sterility with each shipment — documentation available upon request for GMP audit trails and batch records
- USA manufactured and sterilized — both manufacturing and sterilization performed in the USA for supply chain control and regulatory documentation
- Advanced Technology foam — 25% more liquid absorption and 2× more liquid release than competing cleanroom mop foams
- Stainless steel channel — corrosion-resistant; compatible with aggressive disinfectants, autoclaving, and gamma/ETO sterilization processes
- Pull and Lift compatible — refill designed for the Roll-O-Matic® self-wringing handle and the “Pull and Lift” technique specified in most controlled environment cleaning SOPs
Frequently Asked Questions
What sterility level does the 147546 provide and how is it validated?
The 147546 is validated to a Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 11137 — the internationally accepted standard for sterile medical products and cleanroom consumables. This means the probability of a non-sterile unit in the lot is 1 in 1,000,000. A Certificate of Sterility is available with each shipment upon request for inclusion in your GMP documentation and batch records.
What is the difference between the 147546 (sterile) and 119658 (non-sterile) refills?
Both are 10-inch stainless steel CE Roll-O-Matic® refills with identical Advanced Technology foam. The 147546 is factory-sterile — manufactured and sterilized in the USA, validated to 10⁻⁶ SAL per ISO 11137, individually double-bagged with a sterility indicator dot, and accompanied by a Certificate of Sterility. The 119658 is non-sterile and suitable for ISO-classified cleanrooms where validated sterility is not required. Choose the 147546 for aseptic areas, Grade A/B environments, or GMP programs that require documented sterility validation.
How is the 147546 packaged to maintain sterility?
Each refill is individually double-bagged with a lot number and sterility indicator dot on the outer package. The outer bag should be inspected for integrity and the indicator dot checked before opening. Open the outer bag in the cleanroom anteroom or gowning area and pass the inner bag into the clean zone following your facility’s aseptic transfer SOP.
What Roll-O-Matic handles are compatible with the 147546?
The 147546 is compatible with all 10-inch Roll-O-Matic® handles from Vileda Professional. Note that 10-inch refills are not compatible with 14-inch handles. For 14-inch handle users requiring sterile refills, see the 147548.
Is a Certificate of Sterility included with every order?
A Certificate of Sterility is available with each shipment upon request — it is not automatically included but can be requested at the time of order. Contact MTE Solutions at 651-600-3838 to ensure your shipment includes the CoS documentation for your GMP records.
