Functional testing Ensuring compliance with application requirements
CONTACT USNavigating the challenges during drug submission preparation
To ensure that the drug product can effectively fulfill its intended purpose for the patient, it is essential to verify the integrity and functionality of the containment and delivery system throughout the product's lifespan. Therefore, when selecting the system for drug containment and delivery, it is crucial to gather objective data that supports its suitability for meeting the application requirements over the expected lifetime of the drug product. This is even more critical when it comes to the final design verification. Here, objective data proves system reliability and supports the intended commercial success upon product launch. This data-based confidence is also what reviewers are looking for when assessing the submitted drug application dossiers..
SCHOTT Pharma Services offers a comprehensive testing suite for evaluating the functionality of syringe or cartridge systems in combination with their drug products and application-specific conditions. In this way, we support customers in comparing potential systems for data-guided system selection or in collecting data for drug submission dossiers. Additionally, our tests are utilized with customers to identify root causes of any problems occurring throughout the product lifecycle, from development to commercial operation.
Adding objectivity to your system selection and validation
The minimum functional requirements and testing methods for prefillable syringes and cartridges are specified in ISO 11040-4 and ISO 21881, respectively. These international standards serve as the foundation for our method portfolio. Additionally, we have implemented further methods and capabilities to address specific characteristics of the systems, such as sterile hypodermic needles (ISO 7886-1), and to accurately represent application conditions. We are equipped to support our customers with validated methods to evaluate the functionality of syringe and cartridge systems, including their glass, rubber, and elastomeric components. Typical functional testing methods include:
Methods to analyze injection related functional characteristics
- Removal of Tip Cap or Rigid Needle Shield (RNS)
- Skin or septum penetration force and break-loose and gliding force
- Skin or septum penetration force and break-loose and gliding force
- Analysis of delivered dose and total extractable volume
Methods to analyze injection related risks
- Liquid leakage
- Flange or cone breakage
- Septum self-sealing after needle penetration
- Coring/ fragmentation
- Sub-visible and visible particle formation
PartnerLAB: SCHOTT Pharma’s one-stop solution approach to packaging-related testing for drug submission preparation
When it comes to design verification and drug submission preparation, a wide variety of tests must be conducted and coordinated. The PartnerLab approach allows customers to leverage the capabilities and experience of SCHOTT Pharma as an easy and efficient outsourcing solution. As your partner, we not only deliver professional test result to you, but join you on your journey to get the system validated.
Contract lab – Independent and objective analysis of containment components and systems supporting your data-based decision making.
Fully accredited – We are DIN EN ISO/IEC 17025-accredited and FDA-registered to guarantee the acceptability of your study results by regulatory authorities.
Solution comparison – Independent and objective analysis of the suitability of containment solutions from different suppliers.
Sample preparation included – When in the early stage, SCHOTT Pharma can take care of washing, depyrogenation, filling, and sterilizing, so you can start your study promptly.
Functional testing: How to proceed
SCHOTT Pharma's service team of specialists offers support and advice about your pharmaceutical packaging challenge. We provide guidance and a complete process that will take you from initial request to effective solution.
1. Get in touch
Tell us about your current needs using the contact form below or phone us directly (see number in contact information).
2. Receive a study proposal
Based on your information, our scientific experts will advise you and create a customized study proposal that conforms to the latest regulatory guidelines.
3. Quotation and sample requirements
Based on your feedback, we will provide a quotation comprising a detailed study protocol and instructions for sample selection, packaging, and submission.
4. Sample submission
You then send the samples to our laboratories with a completed submission form, proforma invoice, and material safety data sheet.
