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CDMO Services
Aseptic Filling & Contract Manufacturing Services
DCN Dx offers aseptic filling as a service, providing high-quality, controlled manufacturing for research and diagnostic applications. This service ensures the aseptic preparation, filling, and packaging of microbiological media, custom formulations, and other biological materials for research and diagnostic applications.
Aseptic Contract Manufacturing
DCN Dx provides a GMP-compliant, FDA-registered aseptic manufacturing environment for customers requiring sterile fill-finish services. Our process ensures contamination-free production for microbiology, research, and diagnostic applications.
Aseptic Filling Capabilities
.01
Tube Filling & Capping
DCN Dx offers precise aseptic filling and secure capping
for 10mL tubes, ensuring contamination-free handling of
microbiological media and diagnostic reagents.
.02
Pouch Filling
Our aseptic pouch filling service supports select
formats, providing a convenient, sterile packaging
solution for liquid media and reagents. (Contact us
to confirm compatibility.)
.03
Custom Media & Reagents
We formulate and manufacture bulk liquid
microbiological and cell culture media and
reagents, incorporating sterilization and optimized
storage solutions to maintain integrity.
.04
Kitting & Packaging
DCN Dx provides full-service kitting and packaging,
assembling components into complete, ready-to-use
diagnostic and research kits.
Custom Microbial and Cell Culture Media Formulation
DCN Dx provides specialized services for microbial and other cell culture media, ensuring
high-performance formulations for laboratory and commercial use. This includes:
Custom Media
Formulation &
Optimization
01
We can work with our clients to develop and refine
media formulations tailored to specific growth
requirements and research needs.
Growth Media
Testing &
Comparative Studies
02
Our team conducts performance testing of culture
media, comparing effectiveness across formulations
to ensure optimal growth.
Microbial Method
Development
03
DCN Dx assists in designing and validating microbial
testing methodologies, ensuring compliance with
industry regulations and endpoint analysis.
Disinfectant
Qualification
04
We evaluate disinfectants under controlled
conditions, verifying their effectiveness in eliminating
microbial contaminants in regulated environments.
Technical &
Compliance Services
Compliance Services
DCN Dx ensures regulatory compliance with industry standards, providing:
.01
ISO-Certified Facilities
.02
ISO Class 8 Aseptic Room
.03
ISO Class 9 Gowning, Formulation, and Microbiology Rooms
.04
Routine Environmental Monitoring to Ensure Aseptic Conditions
.05
Bioburden Testing
We assess microbial load on materials and surfaces, ensuring compliance with sterility and cleanliness standards in research and manufacturing.
.06
Sterility Testing
DCN Dx performs sterility testing to confirm the absence of viable microorganisms in aseptically manufactured products, supporting regulatory and quality standards.
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