Quality Certificate
Gamma Irradiation for CleanMax® Clean Sterile Cleanroom Apparel
CERTIFICATE OF STERILITY
Sterility Lot Number | Product Release Date: | Sterility Cert Lot |
|---|---|---|
CS20230221-US | April 20, 2023 | 2300577 |
Dose Info | Min Specified | Max Specified | MIN Actual | MAX Actual |
|---|---|---|---|---|
(kGy) | 30.0 | 50.0 | 31.5 | 42.6 |
Manufacturing Lot Number(s): | M2300405 M2300406 M2300407 M2300408 M2300409 M2300410 M2300411 |
|---|
| ITEM NUMBER(S) | SIZE(S) |
|---|---|
| CTL191CS | 2X |
| CTL417CS | XL, 2X, |
| CTL428CS | XL, 2X, 3X, 4X |
Lakeland Industries, Inc., certifies that the Product/Item Number(s) and Lot Number(s) identified above have been processed and released in accordance with specifications and standard operating procedures.
The minimum validation dose has been established in accordance with guidelines outlined in ANSI/AAMI/ISO 11137-1: Sterilization of Heath Care Products-Requirements for Validation and Routine Control-Radiation Sterilization to provide a Sterility Assurance Level of 10˄-6. Do not use if package integrity has been compromised.
Certificates of Sterility can be retrieved online at www.lakeland.com or contact Lakeland customer service at info@lakeland.com.
M. LEE MORGAN, Ph.D., Director of Global Quality
Quality and Compliance
- Industrial Protective Clothing
- Critical Environment
- Fire Turnout Gear
- Hi-Vis Safety Apparel
- 800-645-9291