The Importance of Rigorous Quality Assurance in Sterile Compounding

Introduction

One of my mentors, Dr. Lawrence Trissel, an esteemed expert in chemical testing and stability studies in sterile compounding, conducted a revealing study on contamination rates in pharmaceutical preparations. His findings underscored the critical importance of stringent quality assurance practices in our field.

Dr. Trissel's Study

In Dr. Trissel's study, two lab technicians were tasked with preparing 100 syringes by drawing up liquid-growth media. After setting the syringes aside, they were tested for contamination, which revealed a contamination rate of 5%. On a separate day, under identical conditions except for one change—wiping their hands with alcohol after every third syringe—the contamination rate dropped to about 2%. This simple practice significantly reduced contamination, highlighting the impact of meticulous hand hygiene.

Observations at the AAPS Conference

At a conference held by the American Association of Pharmaceutical Scientists (AAPS), I was captivated by a video demonstration at a pharmaceutical manufacturing booth. The video showed dedicated quality assurance technicians performing high-purity tasks with remarkable precision. After filling vials with drugs, the technician moved to another room for a Fingertip Assessment. This process involved pressing their fingertips onto a growth plate to detect any bacteria present due to production activities.

Fingertip Assessment at Hartley Medical

This stringent procedure is also implemented at Hartley Medical. Fingertip Assessment is a critical component of our quality assurance protocols. However, the industry standard requires this test only once a year, typically right after washing and donning sterile gloves, which minimizes the chance of detecting contamination.

Hartley Medical's Enhanced Procedures

At Hartley Medical, we perform Fingertip Assessments between 1 and 5 pm, during active use. Recognizing that every touch of a syringe, needle, or vial can introduce contamination, we maintain rigorous hand hygiene, wiping our hands with alcohol every other preparation. By conducting random Fingertip Assessments throughout the day, we ensure that the results genuinely reflect our facility's cleanliness and our commitment to quality.

Our Objectives and Commitment

Our objectives at Hartley Medical are straightforward: to minimize contamination rates throughout the sterile compounding process, to maintain an extremely low bio-burden, and to deliver the highest quality care. These goals drive our unwavering commitment to rigorous quality assurance practices.

Conclusion

The practices and procedures at Hartley Medical exemplify our dedication to uncompromising quality in sterile compounding. Through meticulous processes like Fingertip Assessment and continuous hand hygiene, we ensure the highest standards of cleanliness and safety. This commitment to quality is what sets Hartley Medical apart, providing our clients and their patients with the assurance they deserve.

‍