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- Pharmaceutical Pre-filled Syringes Analysis
Pharmaceutical Pre-filled Syringes Analysis
Online InquiryThrough our global network of testing experts and analytical equipment including chromatography (HPLC, GC, GC/MS) and atomic absorption spectroscopy (AAS, GFA, FIAS), Our goal is to provide test services as efficiently as possible to maximize our customers' profits. For more information about our services, contact one of our experts today.
Note: this service is for Research Use Only and Not intended for clinical use.
Pre-filled syringes are a more convenient drug delivery device than conventional syringes. They are small, easy to carry, and reliably deliver accurate doses. Since the drug preparation requires fewer steps than filling into the vial, the risk of drug contamination and drug spillover are both reduced. Therefore, in addition to the need for pre-filled syringes to perform the same tests as regular syringes, periodic batch testing is required during production to ensure product consistency within each syringe. Each new syringe and formulation combination requires full performance and safety verification as required by the FDA.
Alfa Chemistry has accumulated a wealth of expertise in pre-filled packaging inspections, and our application scientists can develop custom inspection methods for your product packaging testing. All of our work can be carried out according to different regulations in different areas, and the most accurate services are provided in the shortest time. For more information on pre-filled packaging testing, please feel free to contact us.
Alfa Chemistry's capabilities include but not limited to:
Performance Testing Compliance with Regulations
Extractables and Leachables
Dose Accuracy and Availability
Toxicity Testing
Biocompatibility Testing
Stability and Sterility Maintenance
Container Closure Integrity
Some test standards we follow include:
ISO 11040 — Prefilled syringes
ISO 10993 — Biological evaluation of medical devices
ISO 8537:2016 — Sterile single-use syringes, with or without needle, for insulin
ISO 11607-1:2006 — Requirements for materials, sterile barrier systems and packaging systems
ASTM D4169-16 — Standard Practice for Performance Testing of Shipping Containers and Systems
Alfa Chemistry's advantages:
Short Detection Cycle
Experienced Team of Experts
First-class Equipment
Competitive Price
Reliable Results
Familiarity with Various Standards
- Recommendation
- Ordering Process
- Ask a Question
Do not know how to place an order, please refer to the flow chart shown below.
Submit quotation request |
A technical manager will contact you within 24 hours |
You will review and approve the final price and place an order |
Confirm with you and make the payment |
Instruct you to ship your samples and form |
Analytic report delivery |
