Ensuring Patient Safety
Ensuring the safety and effectiveness of customized medications is a key priority of compounding pharmacists for protecting patients. However, there are still more than half of a million adverse medication-related events reported every single year to the FDA. This is estimated to be only 10% of all actual adverse events, according to estimates published by the FDA and Adverse Events, Inc.
As a result, federal and state regulators have greatly strengthened their oversight of compounding pharmacies and their methods of enforcement. It is vitally important, now more than ever for compounding pharmacies to evaluate their current processes. The fact is, doing “as good as” or “better than” current standard practices are becoming the expectation of these federal and state officials.
A compounding pharmacy does not have to be doing something “wrong” or be out of “compliance” to change current practices. For many years hands-washing vials or using some sort of a “dishwasher” has been the standard practice in most compounding pharmacies. However, washing vials manually is not only time consuming, it is inconsistent, it often fails to remove contaminants and yields results that cannot be validated. How does one achieve a process that can be validated? Automate it. This is the only way.
Machines are consistent, they repeat the same process over and over again and they guarantee that vials have been cleaned not only for the safety of patients, but within the FDA standards and requirements.
SP PennTech was founded in 1992 as a manufacturer of vial washing and tray loading machines. With this as a foundation, we have been able to design and manufacture the perfect aseptic solution to help keep Compounding Pharmacies USP and cGMP Compliant. For over 20 years we have optimized and perfected the art of vial washing. The objective of vial washing is to remove particulate matter and microorganisms. Traditional vial washers have many moving parts (grippers with springs, penetrating spray needles, chains, moving rods, gears, belts, chains, grease points, etc.) in the washing chamber. Not only do these all generate particulates, but often they also cause glass chipping and vial breakage. SP PennTech vial washers are designed with minimal moving parts and use servo motors rather than gears, belts, and chains.
At SP PennTech, a special emphasis is put on simplistic, yet robust design, adherence to cGMP guidelines, and quality, not only of the machines, but also of the supporting validation documents. Since our founding, SP PennTech has become a world leader in the manufacture of complete aseptic vial production lines. Our success in performance and reliability has led to an ever increasing and diverse product line that includes not only vial washers and tray loaders, but also sterilization tunnels, filling/stopper-inserting machines, automatic lyophilizer loading machines, capping machines, and external decontamination machines. SP PennTech’s specialty lies in low-to-medium speed applications (sub 200vpm); however, we offer many machines exceeding 400vpm. As an experienced and dynamic engineering company, we strive for efficiency by designing equipment with a very small footprint making them easy to maintain, changeover, and operate.