Self-Serve Surface & Air Sampling Kits

Sampling Kits we offer:

• Air Sampling — Viable airborne particle sampling is essential for compliance with USP <797> and <1116> guidelines, which govern sterile compounding and microbiological testing for aseptic processing environments. Viable airborne sampling helps ensure air quality standards are met, reducing contamination risks. When air quality issues are detected, such as elevated levels of viable particles, the data from sampling is crucial for developing and confirming corrective action plans. By identifying sources of contamination, facilities can implement targeted interventions (e.g., improving airflow, cleaning procedures, or material transfer). Regular sampling ensures that corrective actions are effective, maintaining compliance with regulatory standards and ensuring patient and product safety.
• Surface Sampling — Surface sampling for viable contaminants is another essential component for compliance with USP <797> and <1116> guidelines. Surface sampling helps ensure that surfaces in controlled environments remain within acceptable limits for microbial contamination. When surface contamination is detected, the data from sampling is crucial for developing and confirming corrective action plans. By identifying contaminated surfaces, facilities can implement targeted interventions, such as improving cleaning protocols or adjusting environmental controls. Ongoing surface sampling ensures the effectiveness of corrective actions, helping maintain regulatory compliance and ensuring the safety of patients and products.
• Glove Fingertip Sampling — Gloved fingertip sampling ensures personnel adhere to proper aseptic techniques in sterile environments. This testing involves sampling the fingertips of personnel after gowning and glove application to check for microbial contamination. This practice helps verify that individuals are effectively maintaining sterility during gowning procedures. Regular fingertip sampling identifies lapses in technique, enabling corrective actions such as retraining or improvements in hand hygiene. By ensuring personnel consistently demonstrate proper aseptic techniques, gloved fingertip sampling helps maintain compliance with USP <797>, reduces the risk of contamination, and ensures patient safety.
• Media Fill/Aseptic Technique Testing — Media fill testing is crucial for ensuring personnel maintain proper aseptic technique in sterile environments. It involves simulating a compounding process using a nutrient-rich media to detect any microbial contamination that might occur during aseptic preparation. If contamination is present, it indicates lapses in technique, prompting corrective actions such as retraining or process adjustments. Regular media fill testing helps verify that personnel can consistently perform sterile compounding without introducing contamination, ensuring compliance with USP <797> guidelines, preventing patient harm, and maintaining the integrity of sterile products.

What’s included in a Kit?

• Sampling media, packaging materials, shipping container, cold packs, sample labels, chain of custody form, and shipping label
• Media types can include TSA, SDA, or MEA

How do the Sampling Kits work?

You determine the types of samples you need, the number of samples you need, the type of analysis you need, and the frequency you need to perform the sampling. Simply fill out THIS FORM for USP <797> or THIS FORM for USP <1116>, and email it back to us to set up your kit subscription. Our sampling services team will send you everything you need to collect your own samples.

TSS also sells Air Sampling Equipment as a solution to your environmental testing needs.

What do I do with my samples once they’re collected?

• You’ll send samples directly to TSS.
• Enumeration will be processed via an automated colony counter with digital imaging.
• Species level identification will be performed using a MALDI-TOF Smart Biotyper System.
• For USP <797> sampling kits, customers will automatically receive these identifications for any samples that exceed microbial action limits.
• For USP <1116> sampling kits, customers will have the ability to order species identifications up to two weeks after receiving their MAR.

How do I get my results?

• TSS will provide customers with a Microbial Analysis Report (MAR) for each of their chosen samples.
• Each report is reviewed and approved by a laboratory manager and a data quality analyst to confirm the highest quality to our customers.

Need a quick refresher on how to adequately collect samples?

No problem! We offer Instructional Video and Tutorial Packages through our online learning management system.  Customers can enroll an unlimited number of employees into each module.  Additionally, we offer on-site training should your business require in-person training.

Ready to get started?

Simply fill out THIS FORM for USP <797> or THIS FORM for USP <1116>, and email it back to us, or CONTACT US HERE to initiate your DIY Sampling Kit subscription.