Description
SurfaceShield is a wipe sampling kit for the detection of drugs on surfaces at manufacturing facilities, pharmacies, hospitals, and other healthcare institutions.
Sampling with SurfaceShield is a fast, easy, and convenient method for verifying the efficacy of your cleaning program, including deactivation and decontamination. This multipurpose and affordable kit can be utilized to achieve and maintain USP <800> compliance and meet Title 21 Part 211 CFR requirements.
Samples are analyzed at Eagle, an A2LA ISO 17025 accredited laboratory, utilizing highly specific and validated methods for both hazardous and non-hazardous drugs. You can count on Eagle to provide results that are quick, reliable, and accurate.
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SurfaceShield Wipe Sampling and Cleaning Verification Base Kit Includes¹ |
| 2 – Sample Sets (tube, *Texwipe ® swab, single-use vial of sterile water, pair of gloves in reclosable plastic bag, 10 x 10 cm (100 cm²) template)
3 oz single-use cold pack Sampling Instructions insert Blank labels Insulated mailer ¹The base kit can be customized according to the number of sample sets required. |
Pricing
The stated price is for the SurfaceShield Surface Wipe Sampling and Cleaning Verification Kit only and does not include the price of testing. Refer to FAQ #12 or contact Eagle for analysis pricing details.
- Please note that any consumable products purchased cannot be returned or exchanged. All sales of consumable products are final.
FAQs
- How do I collect the sample?Each sampling kit includes a sample instruction card, as well as a QR code that provides access to step-by-step video instruction.
- What solvent should be used when sampling?We recommend using the single-use vial of sterile water that is included in the kit but deionized or distilled water may be used.
- How do I return the sample?Once the samples are properly collected and ready for shipping, they are placed and sealed inside the included insulated mailer. Complete the sample submission process in EagleTrax and mail the insulated mailer to Eagle for processing. If you have any questions about the packing or shipping process or need further assistance of any kind, please contact the Eagle Care Team at 800-745-8916 or info@eagleanalytical.com.
- How often should I be testing?USP <800> states: “Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment).”
- Where do I ship the samples to be tested?Eagle Analytical (Attention To Sample Submission) 11111 S. Wilcrest Dr. S1000 Houston, Texas 77099
- What area(s) should I be swabbing?Excerpt from USP <800>:
Section 6. ENVIRONMENTAL QUALITY AND CONTROL
Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment). Surface wipe sampling should include:
- Interior of the C-PEC and the equipment contained in it
- Pass-through chambers
- Surfaces in staging or work areas near the C-PEC
- Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)
- Areas immediately outside the HD buffer room or the C-SCA
- Patient administration areas
- How large of an area should I be swabbing per location?10 cm x 10 cm (4″ x 4″)
- Where do I submit these samples for analysis?Click to view the Sample Submissions page which goes over the sample submission process.
- What analytes should we be testing?Eagle has the capability to test the following analytes:
API not mentioned? Contact Client Care.
Apomorphine Methimazole Ascorbic Acid Methotrexate Azathioprine Methyltestosterone Carboplatin Oxytocin Cisplatin Progesterone Chloramphenicol Spironolactone Colchicine Tadalafil Estradiol Tamoxifen Citrate Estriol Testosterone Estrone Testosterone Cypionate Ethinyl Estradiol Testosterone Propionate Finasteride Tretinoin Fluconazole Zonisamide Hydroxyprogesterone More To Come - What if I do not see an HD that I would like to test?Contact Client Care at l 800-745-8916 or info@eagleanalytical.com; the option of developing a method is possible.
- How many analytes per swab can be tested?We recommend one active per swab to ensure the highest accuracy.
- What is the pricing of analysis?$250 per analyte/location.
- What do these results mean?A positive result would indicate your cleaning process is insufficient, whether that indicates ineffective dwell time, cleaning SOP, cleaning agent, or other causes.
- What is the turnaround time?Our standard turnaround is 5 business days but samples that are upgraded to rush may be ready in as little as 2 days.
- What is EagleTrax?EagleTrax is a free client portal and sample management system application (found on the Apple App Store and Google Play Store) and desktop portal that allows customers to receive real-time updates on their sample’s progress, view sample results, submit samples for analysis, and more.
Related Services
- 90 mm TSA (Tryptic Soy Agar) Plates – 10 plates per pack
- 65 mm TSA (Tryptic Soy Agar) Contact Plates – 10 plates per pack
- Environmental Monitoring Solutions
Notes
- Our SurfaceShield Surface Wipe Sampling and Cleaning Verification Kits provide you with all the items you need to check a surface for the residue of chemicals including several USP <800> NIOSH APIs. Mitigate business risk by allowing Eagle to verify that the area sampled was cleaned appropriately.
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- A list of hazardous drugs can be found in the NIOSH Hazardous Drug List.
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- Eagle is a U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) registered A2LA ISO 17025 accredited laboratory founded in 2003 that provides analytical and microbiological testing, consultation services, and other technical services for pharmacies and other highly regulated industries including hospitals and pharmaceutical manufacturers to support their compliance needs.
- If you have an active not mentioned in FAQ #9, please contact Eagle Client Care to see how we can help.
- *Texwipe ® is a registered trademark of the Texwipe Company, LCC [Illinois Toll Works, Inc. (ITW)].
- Questions about the SurfaceShield Surface Wipe Sampling and Cleaning Verification Kits? A base kit greater than 10 sample sites are required? Contact Client Care at 800-745-8916 or info@eagleanalytical.com for further details or assistance.
Educational Resources, Related Topics, & Events
- 🔺USP PUBLISHED REVISIONS – WHAT CHANGED?
- The Who, What, Where & Whys of the SurfaceShield Wipe Sampling and Cleaning Verification Kit (Product Information Page)
- Environmental Monitoring (Article)
- Proper Environmental Surface Sampling with Agar Plates (Video)
- Consulting Services & Compliance Solutions (Services)
CLICK TO LEARN MORE | SurfaceShield Wipe Sampling and Cleaning Verification Kit
Eagle is a U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) registered A2LA ISO 17025 accredited laboratory founded in 2003 that provides analytical chemistry and microbiological testing, consultation services, and other technical services for pharmacies, highly regulated industries, and research organizations to support their compliance needs.
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