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.
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 Kit Includes |
| 2 – Sample Sets (tube, 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 |
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.
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 1-800-745-8916 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 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?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.
- What analytes should we be testing?Eagle has the capabilities 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 Tamoxifen Citrate Estradiol Testosterone Estriol Testosterone Cypionate Estrone Testosterone Propionate Ethinyl Estradiol Tretinoin Finasteride Zonisamide Fluconazole More To Come Hydroxyprogesterone - 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?$225 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.
Notes
- Our SurfaceShield Surface Wipe Sampling and Cleaning Verification Kits provide you with all the items you need to check a surface for 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.
- Questions? Contact Client Care at l 800-745-8916 or info@eagleanalytical.com for further details.
Educational Resources, Related Topics, & Events
- 🔺USP PUBLISHED REVISIONS – WHAT CHANGED?
- HIGHLIGHTS from PCCA International Conference & EAGLE SEMINAR 2022! | Industry thought Leaders & influencers presenting topics on cleanroom requirements, environmental monitoring, proposed USP changes, insanitary conditions, & more. #ISTX22 (Hope to see you next year at #ISTX23 in Woodlands, TX! ( ISTX23- Update Page & Video)
- 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 an FDA and DEA registered, A2LA ISO 17025 accredited laboratory providing analytical and microbiological testing services along with expert consulting services to 503A compounding pharmacies, 503B outsourcing facilities, and pharmaceutical companies.
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Kanish Sangani –
This is one of the easiest test kit I have found in the market. It is simple to use and instructions are very clear and to the point. It comes with an ice pack and easy to send back in the package you receive. I would definitely recommend this service from eagle for accurate results. Understanding result is clear and their quality control staff is very friendly to help you with any question when you get the results back.
Eagle Analytical –
Thank you, Kanish. We’ve put a lot of thought into making the kit and its testing be of great value. So, we are super excited to know that you have found the kit to be an easy way to perform sampling and receive accurate results! Thank you for allowing us to assist you, sir. We are here anytime you need us.