Business Details
Innovative Drug Delivery Systems & Active Packaging Solutions
Aptar CSP Technologies is the premier active material science solutions expert that transforms ideas into market opportunities. With over 50 years of experience, we accelerate and de-risk the product development process, providing complete solutions that improve consumers' and patients' lives. Our proprietary 3-Phase Activ-Polymer technology enables innovative, highly engineered material science solutions to meet diverse product stability needs across six key therapeutic areas. We offer a full spectrum of capabilities, including feasibility assessments, solution design, extractables testing, stability studies, and regulatory compliance support.Headquartered in Auburn, Alabama, our ISO-9001, ISO-13485, and ISO-14001 certified facilities operate under Six Sigma quality principles and cGMP standards. We pride ourselves on delivering customized solutions that extend shelf life, ensure product stability, and enhance brand equity for global pharmaceutical, medical device, and food safety clients.
Services
Drug Delivery Systems
Probiotics/Nutraceuticals
Dermal Drug Delivery
Medical Devices & Implants
Diagnostics
Food Protection
Oral Solid Dose
Nitrosamine Mitigation
Extractables Testing
Stability Studies
Highlights and features
- We offer ISO-certified quality management systems for pharmaceutical packaging
- Our proprietary 3-Phase Activ-Polymer technology enables customized stability solutions
- 50+ years of experience in active material science innovations
- cGMP-compliant manufacturing facilities across three continents
- Comprehensive development services from feasibility to commercialization
Associations and certifications
- ISO-9001
- ISO-13485
- ISO-14001
Services
Drug Delivery Systems
Our advanced drug delivery systems control moisture and oxygen to ensure accurate dosage delivery. Using proprietary Activ-Polymer technology, we develop customized packaging solutions that maintain product stability throughout the supply chain. These systems integrate seamlessly with tablet, capsule, and dermal delivery methods while meeting global regulatory requirements.
Nitrosamine Mitigation
N-Sorb technology provides reformulation-free nitrosamine mitigation for pharmaceutical products. This patented solution works within packaging headspace to inhibit formation without altering drug composition. It offers FDA-compliant protection that meets emerging regulatory standards for consumer safety.
Extractables Testing
We conduct comprehensive extractables and leachables testing to identify potential chemical migration risks. Our laboratories perform rigorous characterization of active polymer components under extreme conditions to guarantee product safety and regulatory compliance for pharmaceutical and medical device applications.
Stability Studies
Our stability studies evaluate product performance under real-world conditions. We conduct accelerated testing, temperature cycling, and ISTA shipping simulations to validate packaging effectiveness. These studies support regulatory submissions and ensure long-term product viability across diverse distribution environments.
Regulatory Support
We provide end-to-end regulatory submission readiness including DMF access authorization and FDA inspection preparation. Our team assists with documentation, mock audits, and compliance statements to streamline global market approvals for pharmaceutical, medical device, and food safety products.
Questions
What industries do you serve?
We primarily serve pharmaceutical, medical device, diagnostics, and food safety industries with specialized material science solutions.
What is your core technology?
Our proprietary 3-Phase Activ-Polymer technology simultaneously controls moisture and oxygen to maintain product stability in packaging systems.
Are your facilities FDA-approved?
Yes, our manufacturing plants meet FDA requirements and operate under Current Good Manufacturing Practice (cGMP) regulations.
How do you handle regulatory submissions?
We provide DMF access letters, pre-inspection preparation, and regulatory compliance documentation for global market approvals.
What geographic regions do you support?
We have manufacturing and service locations in the USA, France, Germany, Japan, and China with global distribution capabilities.
How can I request technical support?
Contact our Auburn headquarters or regional offices for technical assistance, product inquiries, or development partnership opportunities.
