To view the answers to any of the questions below, click on the section to expand the list. If your question isn’t answered on these pages, please contact us.
•What is your source for IV bags?
Most of our IV bags are made on site, using Blow-Fill-Seal (BFS) technology, when the compounded drug is ready to be placed in a container. The entire process takes place in a closed system without human intervention. We can produce 50 mL, 100 mL, 250 mL, 500 mL and 1 liter bags. View the Our Process page for more information.
When necessary, we procure IV bags from USP- or EU-approved sources. We validate the quality and sterility of every shipment through our Quality Assurance Department. Specific manufacturer information is available upon appropriate request.
•What drugs do you compound and how can I order?
You can find our current product offering on the Products page of the Web site.
You can order SterRx products through the SAGENT® sales representative for your area.
•What is the source of your IV vials?
We manufacture vials using BFS technology. We can produce 10 mL, 30 mL and 60 mL single-dose vials. We validate the quality and sterility of every batch/lot through our Quality Assurance Department. View the Our Process page for more information.
•What is the source of your syringes?
We procure syringes from USP- or EU-approved sources. We validate the quality and sterility of every shipment through our Quality Assurance Department. Specific manufacturer information is available upon appropriate request.
•What material do you use to make your BFS containers?
Our BFS containers are made from pharmaceutical-grade LDPE (low-density polyethylene) resin.
•Are your containers DEHP-, PVC-, and latex-free?
Yes. View Benefits of SterRx Premixed IV Solutions on the Resources page.
•What IV sets are compatible with your container ports?
The ports are universally compatible with all common IV administration set spikes.
•Are there instructions for spiking the containers?
Yes. An instruction sheet for hanging and spiking our containers is available here.
•Which spikes are compatible with your port? Will they allow access to the secondary port to allow insertion of an IV set?
Any traditional or commercial dispensing spikes will work. SterRx bags will work with your hospital’s protocol compliant with USP 797 guidelines.
•What are the specifications or sizes of the container ports, and what is the maximum spike size that would be compatible with the top?
SterRx containers have standard IV ports.
•Do you use beyond-use dating on your products?
No. We provide expiry dating, a reliable expiration date that exceeds recommended beyond-use dating.
Our expiry dating is proven for up to 180 days and possibly longer.
•Where can I find the beyond-use dating that my pharmacy can use when we add a product to your saline containers?
SterRx uses expiry dating for a more precise statement of product viability. The expiry dating is shown on each container label. It is also shown on the CoA that accompanies every order.
•Is your bar code on the overwrap the same as the code on the bag?
Yes. These bar codes are the same.
•If we admix your product, how do we seal and/or mark the top to let others know it has been changed?
You would follow your regular protocol. However, our port caps would clearly indicate that the port cover has been removed.
•Is there any information addressing the possibility of leaching for your containers?
Every product is researched in its final container for stability, including leachables and extractables.
You can read a study on this subject here.
•How many days of dating can I give sodium bicarbonate if it is removed from the overwrap?
•How much volume can be added to the SterRx 250 mL NS bag?
10 to 20 mL with no air exchange, and up to 60 mL with an air exchange.
•What other products are in your short-range plan for production?
Please visit the Coming Soon page of the Products section of our Web site.
•In what states are you registered?
•Has your facility undergone an FDA inspection?
Yes. The SterRx facility, in Plattsburgh, New York, was inspected by FDA to initiate registration of the facility with the New York State Board of Pharmacy.
•How do you expect to compete with older, established outsourcing facilities in this new field of 503B compounding?
SterRx’s background is sterile drug manufacture. Only since the passage of the Drug Quality & Safety Act has SterRx been allowed access to this market. SterRx staff has extensive background in cGMP drug manufacture, automated form, fill and seal and significant capacity compared to the current market suppliers. SterRx has entered the market at the highest level of compliance and product capacity.
•How is SterRx different from other 503B facilities?
The SterRx founders were industry leaders in aseptic packaging of medical devices and pharmaceuticals, where cGMP has always been the standard. Our experienced SterRx team comes from the sterile drug manufacturing world, while most companies hire pharmacists who must transition up to the cGMP environment with higher standards. Pharmacists and pharmacies typically operate under state law only, whereas SterRx operates under FDA oversight and cGMP rules of compliance.
SterRx uses the same processes as those used for commercially available drugs, producing sterile compounds from non-sterile ingredients. These include sourcing API from FDA-approved manufacturers to formulate and produce sterile products.
While other compounders use beyond-use dating, SterRx uses expiry dating, a more precise statement of product viability. Our ability to provide customers with a precise expiration date is possible because of our in-house stability testing, which includes product testing in real and accelerated time.
•Why didn’t I see any hoods in the compounding area when I visited your facility?
Because SterRx does not produce any drugs manually, hoods are not needed. All our products are manufactured, and packaged, in an enclosed BFS system that eliminates human intervention in the form, fill and seal processes.
•What procedures does SterRx have in place for Quality Assurance?
SterRx has a rigorous Quality Assurance program.
- All incoming materials are quarantined until documentation and release by Quality Assurance.
- SterRx qualifies all equipment and validates all processes and products.
- The entire facility is environmentally monitored, along with clean rooms and equipment.
- All drugs are placed on stability to establish science-based expiry dating.
- All products are released only after testing to cGMP standards.
- All products are tested for sterility and endotoxins prior to release.
- SterRx has a dual (side by side) independent Quality Assurance System, the normal cGMP system used by drug manufacturers and a 503B pharmacy-based system. No drug can be released until both systems have signed off.
For more details, visit the Resources page and click on SterRx Quality.
•How can I obtain a Certificate of Analysis?
A CoA is included with every order for every lot. If you need an additional copy, you can request a copy for the lot in question by going to Contact Us and choosing the CoA/Quality Assurance category from the drop-down menu. You will find the lot number on the product label.
•Where can I find your quarterly QA report?
Go to the Resources page and click on “Quarterly Reports,” or contact Customer Service and request a copy.
•How/where can I check my order status?
Contact Customer Service or your SAGENT sales representative and request a status report.
•How can I track my shipment?
If the contact person on the order placed did not receive a carrier alert, you can contact Customer Service for assistance.
•How quickly will my shipment go out after I order?
SterRx strives to ship within one full business day of order receipt for all goods in stock. However, as a 503B compounder working with a range of batch sizes with variable shelf life/expiry dating to contend with, we often have pre-booking of orders prior to an available ship release. To best manage your order delivery, work closely with your SAGENT sales representative to confirm the expected processing time for a specific product.
•What are your extreme weather shipping policies?
SterRx does not apply any specific constraints with regard to weather-related temperature variations. However, depending on the nature of a specific order, we make an effort to mitigate shipping during extreme cold weather to help minimize freezing risk during transit.
•How will you handle recalls? Will you track my product and lot purchases and only notify me if we purchased that product and lot?
Should a recall be necessary, SterRx will alert the customer and representative by email and will follow up by phone to confirm receipt and action as appropriate.
•How can I apply for a job at SterRx?
You can send a résumé and references/credentials, along with a cover letter, for the position for which you believe you are qualified. Visit our Careers page.
•How can I reach SterRx Customer Service?
You can call 518-324-7879 or email customerservice@SterRx.com. You can also fill in the Contact Us form. We will get back to you within one business day.