Frequently Asked Questions
FAQ
Frequently Asked Questions
Getting Started
Ordering, delivery & onboarding
Manufacturing
Inks, tablets, cleaning, APIS
Regulation, Governance, and Safety
Compliance, cyber security and classification
General
Connectivity and manufacturing
Getting Started
Who benefits from your technology?
The Pharma Printer is made for hospital and retail pharmacies, including at point of sale. It is also designed for the pharma industry and veterinarians.
How can I order a Pharma Printer?
From our webstore or via contacting sales. or via contacting sales. goes here.
Where can I get Excipient Bases?
You can order GMP manufactured Excipient Bases from our webstore or via contacting sales.
What is the delivery time of Pharma Printer?
The delivery time is approx 6-8 weeks, depending on order volume.
Do you have solutions for both human and veterinary medicine?
Our technology is effective for both human and veterinary medicine.
I want to do test printing. Can I order technical Excipient Bases for research purposes?
Yes, this is possible from our webstore or via contacting sales.
How long does it take to learn how to use your solution?
Our solution is easy to use and it takes only an hour to learn the Pharma Printer and quality control tools
What is the price of the Compounding System Solution?
We offer several pricing options, including purchase or a model based on a minimum order of Excipient Bases. There is no charge for formulation development. Instead, customers may subscribe to our formulation library.
Would you like a quote? Please contact us, and we are happy to help you forward.
How will we validate the technology?
Typically, we perform a IQ/OQ of the Pharma Printer with the customer. The technology is ready to use after this and training.
Manufacturing
How long does it take to print one tablet?
It takes 1-3 seconds to print one dose.
How many tablets can you print in one printing round?
It is possible to flexibly print several dozen tablets at one time, depending on the size of the tablets. On average, 1000 doses can be printed in an hour with quality control. In some instances, printing may be faster.
How is the device cleaned, and how long does it take?
Is it possible to print tablets directly into blisters?
Yes, it is possible to dose into blisters, molds or vials.
How do you make the labeling for blisters?
What APIs are available for use with Excipient Bases?
Use the Compounding System Solution to dose chewable tablets, suppositories, or liquids - all with one device and without changing the extruder. You can dose API’s ready to be used with our Excipient Bases or your own. We provide a formulation library of more than 200 API’s that our customers are compounding today.
These include stability data and dissolution profiles.
How does the built-in quality control work?
We have an integrated analytical scale to measure individual weights of the dosage forms and in-process NIR control to evaluate the blend uniformity of the Pharma Inks prepared at the pharmacy. Documentation and batch record is available in our formulation library.
Do you have a PZN number for Germany?
Yes, the CuraBlend has a PZN number which is 19290012.
Regulation, Governance, and Safety
How do I know if the Pharma Printer is compliant with regulations in my country?
CurifyLabs is compliant with existing regulations for pharmacy compounding. We provide the following:
- Our quality management system is compliant with ISO 13485
- CE marked for IEC 61010-1 (classified as laboratory equipment)
- We provide quality documentation for printable pharma ink bases which can be used with several API’s. As our customer you have access to all necessary quality documentation (stability, dissolution, batch records, cleaning protocols etc)
- All raw materials are compliant with the European pharmacopeia.
- Excipient Bases are GMP manufactured and classified as medicinal intermediate product.
- We offer in-process quality control of mass and blend uniformity.
How do you ensure cyber security?
Pharma Printer cannot be accessed directly from the Internet. CurifyLabs also recommends installation behind a company firewall.
CurifyLabs’ Web App is regularly subjected to 3rd party cybersecurity testing.
Is your solution GDPR compliant?
Is the Pharma Printer a Medical Device?
Pharma Printer is not a medical device. It is a laboratory equipment comparable to, for example, HPLC.
General
Can I use the Pharma Printer for research?
The Pharma Printer has a simple-to-use interface designed for busy pharmacies. We offer additional research features for customers who require it.
Where is the Pharma Printer manufactured?
Pharma Printer is designed and manufactured in the European Union.
Could we have the components of the Excipient Bases (allergy risks, suitability for neonate and pediatric patients)?
I want to use my own bases, is this possible?
Yes. To ensure the best dosing experience and utilize our extensive formulation library and Excipient Bases, we recommend using inks that we have been validated with the Compounding System Solution. These also include stability data, dissolution profiles, and other required documentation for regulators.
Our Excipient Bases are based on over a decade of academic research and built by over 50 pharmacists.
Do you offer maintenance and service?
We offer 3 service plans for your convenience.