| What is the shelf life for Berkshire’s sterile wipers? |
A three-year shelf life has been identified for Berkshire’s dry sterile wipers packaged in the gamma header bag and pre-wetted sterile wipers. The expiration date is either on the pack label or embossed in the seal.
Even with a known shelf life it is highly recommended that before use, the primary packaging is inspected to ensure there are no holes or scratches in the package material and that the seals are intact or other damage that would compromise the sterility of the wipers.
|
| |
| How are Berkshire's wipers sterilized? |
Berkshire's line of Sterile Wipers are gamma irradiated to a Sterility Assurance Level of 10-6 (SAL). Sterility Assurance Level (SAL) is the probability of a viable organism being present on a product unit after sterilization. A SAL of 10-6 is the probability of one non-sterile unit in one million.
Berkshire's Validation Process Flow Chart
|
| |
Tell me more about Gamma Irradiation? |
Berkshire employs gamma irradiation sterilization in accordance with ANSI/AAMI/ISO Standards.
Gamma Irradiation
- Widely used method of sterilization
- Cobalt-60 ionizing energy
* lethal effect on microbial populations
* high penetration
- Reproducible and reliable process
* dosimetric release (no quarantine time)
* based on exposure time to gamma rays
→ dependant on desired SAL and bioburden
→ size and density of product
→ dose measured by dosimeters
- Safe Process
* strict safety regulation
* concrete radiation shield, storage pool, safety systems
|
| |
| Does Berkshire supply a Certificate of Sterility with each of its sterile
products? |
Berkshire supplies a Certificate of Sterility, which is placed in a separate shipping label pouch on the outside of each carton of sterile product. Certificates of Sterility can be downloaded by product and lot number from our website.
- A Lot Number is provided on each pack and case for traceability.
- The expiration date is listed on each Certificate of Sterility.
|
| |
| Do you offer pre-wetted sterile wipers? |
Our sterile pre-wetted wipers are validated according to ANSI/AAMI/ISO guidelines. They are pre-wetted with 70% USP (United States Pharmacopeia) Grade Isopropyl Alcohol (IPA) filtered to 0.2 µm. Material Safety Data Sheets are available online for these sterile wipers.
Technical Data Sheets
Sterile SatPax® 1000
Sterile SatPax® 1200
Sterile SatPax® 670
Sterile SatPax® HA |
| |
| What can you tell me about sterile package testing for Berkshire's wipers? |
| Package Validation is the key to maintaining the integrity of your product. Material compatibility, package sealing, barrier performance are just some of the key aspects that must be evaluated for the packaging. Berkshire's packaging validation is performed on sterilized packaging according to ASTM F1140-00: Standard Test Method for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications. Berkshire performs Burst Testing Sterility Validations to support the Quarterly Validation Program. As long as the pack has not been compromised, your product is validated sterile. |
| |
| What is sterile vs gamma irradiated? |
| Sterile refers to a product that is validated sterile. ANSI/AAMI/ISO procedures have been followed for verification of irradiation dose with quarterly audits being performed to monitor bioburden levels and dose. The Sterility Assurance Level (SAL) can be determined and is 10 -6 (which is the chance of 1 non-sterile unit in 1,000,000) Gamma Irradiated refers to a product that has been irradiated at some predetermined dose which is felt to kill the bioburden. Sterility testing is usually not performed nor quarterly audits for continued validation. The SAL cannot be predicted. |
| |
| Is the validation process the same for sterile pre-wetted vs. sterile dry wipers? |
| Yes, the validation process is the same for pre-wetted vs. dry as they both follow ANSI/AAMI/ISO 11137. The product is saturated, packaging is sealed and then the cases are sent to be irradiated. They are irradiated wet. |
| |
| Where are irradiation dots and what do they mean? |
| Irradiation indicators are not an indication of sterility. They indicate that product has been exposed to irradiation. The color changes from yellow to red due to a shift in pH. Indicators are typically placed on the outer packaging (on the case) for inventory control purposes. Indicators can also be placed on inner packages.
Under some conditions such as high heat, prolonged UV light, direct sunlight or exposure to alkaline conditions the irradiation indicators may turn orange or orange-yellow. Because of this they should not be depended upon to indicate sterility of the product. |
| |
| How is Gamma Wipe SuperSorb™ (#GWSS.ST.16) packaged? |
| Gamma Wipe SuperSorb™ is packaged in cracker 4 packs. Cracker packaging refers to taking 4 packs and bundling them together in a polyethelene bag; there will be 4 bags of 4 packs each in a case for 16 packs per case. Each pack has 10 sheets. |
| |
| Do you have any information about managing sterile cleanroom consumables? |
| Click here to read "Sterile Cleanroom Consumables Managment" written by Lynn Stanard, Quality Manager for Berkshire. This paper appeared in Cleanrooms Magazine. . |
| |
 |
| |
