With the addition of new state-of-the-art equipment
San Diego, California – Did you know that IRISYS has commercial GMP manufacturing capabilities? Most of our clients have known us as their go-to CDMO for formulation development and clinical supply manufacturing. We have also been the proud single source manufacturer for multiple brand name and OTC commercial pharmaceutical drug products such as Donnatal®, an Rx product for irritable bowel syndrome.
To meet the ever-changing demand of commercial pharmaceutical manufacturing, we have recently made significant investments in multiple new automatic types of equipment to expand our capabilities and increase throughput. Below are just a few shining examples to showcase the newest additions that have been up and running at our cGMP facility located in San Diego, California, one of the hottest biotech hubs.
Automatic Syringe Filling Machine for Gel Dosage Form
The filling line is fully automatic with multiple robotic arms for delivery of syringes to the filling station, syringe rectification, filling, capping, inspection and release. It can also be used in combination with a powder filling machine, allowing manufacturing of dual syringe products. Together, the system delivers products with a powder-filled syringe and a gel-filled syringe which can be interconnected for instant mixing prior to drug application allowing single or multiple uses. It is an innovative way to increase shelf life for otherwise insufficiently stable dosage forms.
To get a glimpse into how it works, watch the video below or follow this link to our website: https://irisys.com/video-automatic-syringe-filling-machine-for-gel-dosage-form/
Automatic Serialization Equipment
As you may know, to reduce counterfeiting of pharmaceutical products, a new law has gone into effect for mandatory serialization by assigning a unique serial number to each saleable unit of a prescription drug which allows the capability to “track and trace”. All commercial CMOs are now required to meet new serialization regulations.
IRISYS has risen to the challenge and invested in new serialization equipment. It has been successfully implemented in our packaging and labeling process. This is in addition to several other automatic labeling machines at IRISYS. We are very well positioned to help you succeed under the new regulatory environment.
Automatic Thermoforming Blister Packaging Machine
IRISYS has recently added a new custom-made blister packaging machine. The machine with a thermoforming process automatically creates blister trays with a specific shape in a mold, fills capsules in the cavity and seals the blister, with all steps automatically completed without manual intervention. We also have a separate testing unit that can check the proper closure of each sealed tray and reject the disqualified ones.
If you need a CMO that can meet the special needs of a unique manufacturing process for your drug product, or if you are stuck with other CMOs that can’t meet the new serialization compliance, we would like to hear from you. We have made pharmaceutical products that have been used by patients around the globe. Please also stay tuned for updates on our new equipment for clinical supply manufacturing and formulation R&D which is coming soon.
About IRISYS (irisys.com)
IRISYS was founded in 1996 to provide contract pharmaceutical product development and manufacturing services, specializing in formulation development, cGMP / GMP manufacturing of clinical trial materials and commercial pharmaceutical products, and strategic consulting related to the drug development process. IRISYS’ custom approach to drug development is supported by the Company’s scientific and regulatory experience in moving more than 100 drug products from discovery to clinical development and commercialization.