Do you require assistance with injectable formulation development? This company has become a key player in the injectable development industry. You can rely on their representatives as they have conducted inspections worldwide.
This research and development organization boasts a wide range of sterile service capabilities, including small molecule and biological fill capabilities, as well as the ability to handle controlled substances, potent compounds, and testing.
Here are a few batching specifications that you can anticipate working with this firm:
- Small Molecules
- Biologics
- Controlled Substances DEA Class I – V
- Batch Sizes Up to 1,500 L
- Jacketed/Insulated Mixing Vessels
- Solutions
- Suspensions
- Emulsions
They are capable of performing sterile aseptic processing and terminal sterilization. In addition to the RABS filling lines, they have acquired new packaging.
You may encounter aseptic filing specifications that require adherence to certain standards. It is important to ensure that these standards are followed in order to maintain a professional and organized environment.
- Filing Lines Utilize RABS Technology
- IMA Extrema Filler
- IMA SteriFil Filler
- High-Speed Filling
- Small Batch Filling
- Glass Vials 2, 5, 10, 20, 50 and 100 ml
- In-line Washing and Depyrogenation
Decades of Experience
Drug development is an area in which experience is highly valued, and this team has a wealth of experience. They develop in a modern, state-of-the-art facility with a sterile injectables program. They can take a product from development to commercial manufacturing, scaling up or down to meet the customer’s needs. With their strong regulatory track record, they are the ideal choice.
Here are some of the packaging details you can expect:
- Fully Automated Secondary Packaging of Vials
- Cold Chain Storage
- Automated
- Semi-Automated
- Manual Inspection for Finish
Contact Renaissance Lakewood LLC at www.renpharm.com.
