Terminal Sterilization
Aluris provides comprehensive terminal sterilization services tailored to meet the diverse needs of in vitro diagnostics, medical device and combination product companies. In conjunction with our qualified third party service partners, our expertise spans multiple terminal sterilization modalities. With capabilities in formulations, filling, lyophilization, assembly, packaging and a full QC laboratory, we offer an integrated approach to meet your manufacturing requirements.
Our terminal sterilization foundational services include the following:
- Formulations, including complex formulations
- Filling
- Lyophilization
- Packaging
- Terminal sterilization
Extended cGMP manufacturing — from routine to complex solutions:
- Sourcing of raw materials and components
- Labeling
- Device assembly and testing
- Storage and distribution support
Learn more about our available services. Talk to an expert.
Quality Control Services
Analytical and microbiological testing service including:
- Bioburden
- Endotoxin
- pH, TOC, conductivity, specific gravity, refractive index
- Spectrophotometry
- HPLC
- Client specific method transfer
- Stability studies
Learn more on the Analytical and QC Services page
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Why Choose Aluris
Unlike other contract manufacturers, we do not develop or sell our own line of products, 100% of our resources are dedicated to our client’s success.
- No minimum batch size
- Engineering batches
- Manufacturing assessments
- Flexibility and Scale
- Integrated, end-to-end solutions
Prioritizing quality from day one, the Aluris Quality Management System is the overarching structure.
Aluris is FDA cGMP and ISO 13485:2016 compliant.
Resources to help you choose a contract Manufacturer
Whether you are just starting to consider if a contract manufacturer is right for you, or are an experienced operations professional looking to hone your outsourcing game, Aluris’s free resources can help guide the way.
Latest Guides:
Non-Sterile Fill Finish Services – How to Evaluate a Contract Manufacturing Organization
Deciding to engage a contract manufacturing organization (CDMO) for your non-sterile fill finish needs can bring a number of rewards, including manufacturing flexibility, reduced capital expenditures, speed to market, and scalability.
FAQs
Aluris Terminal Sterilization FAQs
Q: What types of containers and closures do you support in terminal sterilization services?
A: We handle a wide array of formats for non-aspetic fill finish including bottles, vials, tubes and custom configurations.
Q: What is the minimum batch size you can accommodate for terminal sterilization services?
A: There is no minimum size.
Q: Can you handle both liquid and lyophilized (freeze-dried) products in terminal sterilization services?
A: Yes- this is a core competency as we have our own lyophilization facility.
Q: What sterilization methods do you offer or have access to through partnerships?
A: Gamma/ Ebeam/ Ethylene Oxide/Moist Heat/Dry Heat/ and Vaporized Hydrogen Peroxide are offered through our ecosystem.
Q: How do you ensure quality control during terminal sterilization processes?
A: Aluris has a full in-house QC lab to meet your specifications. We can assess many controls including sterility testing, endotoxin testing, and other safety tests, to ensure product safety and compliance.
Q: Do you provide packaging, labeling, and storage services as part of your terminal sterilization services offerings?
A: Yes- we offer full packaging, labeling, storage and distribution services.
Q: Can you source raw materials and components for my terminal sterilization project?
A: Absolutely- we offer a turn-key sourcing solution which simplifies supply chain management and reduces lead times.
Q: What are your lead times for terminal sterilization services, from initial engagement to product delivery?
A: This is largely dependent on the complexity of the project, readiness for manufacturing, and availability of materials. Pilot projects or engineering builds can often be executed in less than three weeks.
Q: Do you offer formulation development, or do you only work with existing formulations?
A: Aluris specializes in taking pre-determined formulations and scaling up manufacturing to achieve your required batch size.