A drive towards preservative-free formulations
Growing concerns about preservative safety and increasing regulatory concerns, especially from the
European Medicines Agency (EMA), are fueling demand for preservative-free formulations — including
nasal spray drug products. This trend is requires formulation without preservatives.
Meeting this rising need for preservative-free products requires specialized capabilities and expertise
to support their complex manufacturing.
Find out how we can bring your preservative-free nasal spray drug product to patients.
Progressing your preservative-free
product seamlessly
Take your nasal product from clinic to commercial by harnessing our aseptic nasal filling line.
Our dedicated preservative free filling line fills and assembles nasal products in a Grade A environment.
Meeting your preservative-free needs with flexibility
Enhance your nasal spray drug product manufacturing with our flexible, preservative-free capabilities, supporting nasal spray solutions, thin gels and emulsions.
Our preservative-free filling line also accommodates multiple types of nasal spray pumps.
Meeting preservative-free needs with extensive nasal spray expertise
Ensuring quality at every step
Your preservative-free product deserves the highest quality at every stage of production, and we are committed to delivering just that, leveraging:
- In-line Sterile filtration, vial washing, and depyrogenation prior to filling
- Extensive environmental and personnel microbial monitoring
- Robust, validated cleaning procedures
Safeguarding sterility
For your preservative-free formulation, sterility is key.
Our in-house sterility testing, along with ICH- compliant stability chambers (including Zone IVb), ensures the quality and safety of your product throughout manufacturing, registration and commercialization.
Leveraging an unmatched
regulatory track record
Ensure that your preservative-free drug product meets evolving regulatory standards with the support of our in-house regulatory affairs team at every step.
We work with you to demonstrate that sterility and device container-closure integrity are maintained throughout the shelf-life of your product and during the use of multi-dose formats.
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