From preparative chromatography to the final crimp, DIAGNOSEX designs, builds and qualifies the process equipment behind sterile injectable and biopharmaceutical manufacturing — as a single station or as one coordinated production line.
| Peristaltic transfer & dosing25 µL – 10 mL · ±2% |
| Rotary fill–finish lines80 – 300 vials/min |
| In-situ stoppering dryers0.2 – 3.24 m² · −75 °C |
| Vial sealing stations2 – 30 mL · 16/22 mm |
Every platform is available individually for line retrofits — or combined into a coordinated, qualification-ready line managed by one accountable partner.
Dynamic axial-compression columns purify synthetic peptides, GLP-1 analogues, oligonucleotides and small-molecule APIs — from gram-scale method development to multi-kilogram production campaigns.
Servo-driven peristaltic pumps dispense from 25 µL to 10 mL with ±2% accuracy and less than 1% drift over 12 hours — CIP/SIP-ready for biopharmaceutical aseptic transfer and high-precision vial filling.
One continuous GMP workflow — bottle sorting, servo filling, stoppering, cap hanging and crimping — for liquid and suspension products at production speeds, with optional laminar-flow and CIP/SIP modules.
LGJ-series in-situ silicone-oil freeze dryers scale one continuous path — from a 0.2 m² laboratory unit to a 3.24 m² production chamber — with ±1 °C shelf uniformity at −75 °C and hydraulic stoppering under vacuum.
Electro-hydraulic stopper insertion and pneumatic indexing-dial crimping close the sterile injectable line with a hermetic, tamper-evident seal — precise, repeatable and adjustable per product format.
Peptide API purification and lyophilized formulation for GLP-1 analogs and custom peptides.
Recombinant insulin purification, sterile filling and freeze-dried powder production.
Lyophilized and liquid vaccine formulation, aseptic vial filling and sealing.
Powder-for-injection production with sterile filling and crimp sealing.
Answers to common questions about the five platforms, integrated line engineering, GMP compliance and the support you can expect from DIAGNOSEX throughout your project.
Both. Every platform — purification, fluid handling, aseptic filling & capping, freeze-drying and vial sealing — is available as a standalone station for R&D, pilot or production scale, or for retrofitting into an existing line. Alternatively, the platforms can be engineered into one coordinated, qualification-ready line with matched capacities, materials and control philosophy.
Share your target product, batch size, container format and throughput requirements, and our process engineers will map the appropriate stations and capacities for you. Most projects start from the molecule and its stability profile — for example, heat-sensitive or biologic products typically add the freeze-drying and in-situ stoppering route instead of standard liquid filling.
No. Freeze-drying is an optional module in the overall workflow. It is included when the product is a lyophilized formulation, where the line runs filling → freeze-drying with in-situ stoppering → crimping. For liquid formulations, the standard route is filling → capping → crimping, and the freeze-drying station is simply omitted.
Yes. That is the core idea behind our integrated approach: one accountable partner covering the full fill–finish journey — preparative purification of the API, sterile-safe fluid transfer and dosing, aseptic filling and capping, optional lyophilization, and final stoppering and crimping — with matched specifications at every hand-off point between stations.
Every DIAGNOSEX system is engineered and manufactured in accordance with current GMP principles. Each unit ships with a complete documentation package — general arrangement and P&ID drawings, material certificates, calibration records and FAT/SAT protocols — with IQ/OQ/PQ support available to accelerate your qualification.
Yes. Systems are configured around your actual process — product characteristics, batch size or throughput, container and dosing formats, available utilities and cleanroom layout. Options include wetted materials and surface finish, automation and data-integrity levels, and skid or line layouts engineered to fit your existing rooms.
Please share your target product or material, batch size and throughput, container or dosing format, and any purity, accuracy, utility or regulatory requirements. Our process engineers will recommend the right platform combination and return a formal proposal, typically within 2–5 working days.
Standard configurations are generally delivered within 30–60 days from order confirmation; custom-engineered lines are quoted with a milestone schedule. After delivery we provide supervised installation and commissioning, operator and maintenance training, genuine spare parts for the full service life, remote assistance and responsive on-site service backed by warranty.
