WHY SterRx

Our Process

What you don’t see at our manufacturing facility: laminar flow hoods and human hands touching the product. Because patient safety is our first priority.
That’s because our manufacturing process is automated and performed in one enclosed piece of equipment. The only human involvement is the loading of the API into the machine. After that, our BFS technology takes over. BFS ensures that the drug is both compounded and packaged without any human contact, greatly reducing the risk of contamination and errors. The FDA states,
"The advantages of BFS processing are known to include rapid container closure processing and minimized aseptic interventions."1 We use the BFS process to produce IV bags, single-dose injectable drug vials, syringes (isolator filling) and unit- and multiple-dose ophthalmic drugs. You can follow the process on the diagram below.
1 https://www.fda.gov/downloads/Drugs/Guidances/ucm070342.pdf, page 50. Accessed December 1, 2017.

Our Process

1

Ordering

2

Testing

3

API
released &
measured in
dispensing lab

4

ingredients enter mixing tank

5

automatic mixing & transport

6

drug filtering

7

LABELING / PACKAGING & CoA

8

Sample Testing

Placeholder Step 1
Step 1 of 8:

Ordering

API is ordered from a 510 FDA-registered facility.
Step 2 of 8:

Testing

Every order of API is tested to ensure that the product matches the vendor-supplied specifications.
Step 3
Step 3 of 8:

API RELEASED & MEASURED IN DISPENSING LAB

QA releases the API for use in manufacturing. The API is measured in a dispensing lab.
Step 4
Step 4 of 8:

INGREDIENTS ENTER MIXING TANK

The API, excipients and diluent are added manually to the mixing tank.
Step 5
Step 5 of 8:

AUTOMATIC MIXING AND TRANSPORT

Water for Injection is pumped into the mixing tank, and the compounded drug is automatically mixed and then transported to the BFS machine via stainless lines that have been cleaned and sterilized.
Step 6
Step 6 of 8:

DRUG FILTERING

The resulting product is run through a 0.2-micron sterilizing filter inside the BFS machine just prior to forming, filling and sealing the containers.
Step 7
Step 7 of 8:

LABELING/PACKAGING & CoA

The finished drug products (vials, bottles or bags) are labeled and packaged with a Certificate of Analysis, which is sent automatically with every order.
Step 8
Step 8 of 8:

SAMPLE TESTING

Finished product samples are pulled and tested for potency, quality, sterility and endotoxin before the order is sent to the customer.