Control Your Cleanroom for Compliant Compounding

 

Edge Clinical drug trials

 

Edge Pharma offers a comprehensive compounding program for pharmacists and pharmacy technicians engaged in compounding sterile drug products within their organization. This 3-week course is focused on the physical requirements of compounding. The first two weeks will take place in our FDA-registered 503B Outsourcing Facility. During the final week, one of our experts will go on site into your facility to assist in the implementation of skills and protocols learned during the program.

Our experts will take participants through the same training modules as our own production team. Areas of focus include:

 

  • Introducing materials into an Iso 7 area
  • Introducing materials in an Iso 5 area
  • Gowning protocol
  • Personal hygiene
  • Understanding first air
  • Designing and executing a media fill
  • How to conduct surface sampling
  • How to conduct viable and nonviable air sampling
  • How to conduct personnel plating (gloved fingertip, gown, etc)
  • What to do when you find a CFU
  • How to clean classified areas

 

Week 1

Week 1 includes learning support activities that are critical to maintaining control of the cleanroom and completing gowning validation (must have gowning validation prior to beginning week 2).

 

Week 2

Week 2 takes place largely inside one of our cleanrooms.

 

Week 3

Week 3 takes place on site in your facility where one of our experts will aid in the implementation of principals which were taught in the course.

*Weeks do not have to be completed consecutively 

 

Continued access to our team of experts is available after completion of the program.

Each participant will receive a certificate of completion to recognize their competency in each module.

We believe the foundation to a successful compounding program begins with an elite group of cleanroom personnel who have a strong understanding of what it takes to maintain a clean environment.

 

Regardless of whether a facility is routinely inspected by FDA, it is critical that both state-licensed pharmacies and outsourcing facilities prevent the occurrence of insanitary conditions within their facilities.

-Insanitary Conditions at Compounding Facilities – FDA Guidance for Industry

https://www.fda.gov/media/124948/download

 

Call us 802-992-1178 (9am-5pm Mon-Fri) or send us a message if you are interested in our consulting services. A member of our team will reach out to you shortly.