Vedax Pharma Mach Engineering is proud to announce the successful export of an eight-machine complete pharmaceutical format changeover package to a leading sterile injectable manufacturer based in São Paulo, Brazil. The package includes sanitary SS 316L starwheels, servo infeed timing screws, and electropolished guide channels certified under international cGMP and ASME BPE standards.
Full Material Traceability & cGMP Documentation Package
Every component in the Brazilian shipment was manufactured under rigid ISO 9001:2015 quality oversight and delivered with an exhaustive qualification dossier to support rapid ANVISA (Agência Nacional de Vigilância Sanitária) site validation:
- EN 10204 3.1 Material Test Certificates (MTC): Full heat-batch chemical composition and mechanical verification for all SS 316L fluid-contact parts and FDA-compliant polymers.
- Sub-Micron Surface Finish Certification: Fluid-contact channels independently tested and certified at Ra ≤ 0.2 μm (8 μin) with laser profilometer scan graphs.
- Cleanroom Ultrasonic Passivation: Chemical nitric-acid passivation per ASTM A967 followed by final packaging in double-sealed anti-static cleanroom pouches.
- Dimensional CMM Inspection Reports: 100% coordinate measuring inspection ensuring ±0.015 mm interchangeability with existing OEM rotary filling turrets.
Custom Format Engineering for Multi-Format Aseptic Vials & Cartridges
The supplied tooling package enables our Brazilian client to handle 2 ml, 10 ml, and 20 ml glass injection vials as well as 3 ml dental cartridges on the same high-speed aseptic filling and crimping line. All assemblies utilize tool-less quick-release pins and color-coded changeover tracks, cutting format swap changeover time from 60 minutes down to just 12 minutes.
Remote Factory Acceptance Testing (FAT) with Live Container Trials
Prior to international air dispatch, comprehensive Factory Acceptance Testing (FAT) was conducted via high-definition multi-camera live video streaming. Real client-supplied glass vials were run through the tooling on our factory test rig at speeds of 300 containers per minute, confirming zero container tipping, zero label scuffing, and perfect starwheel pocket engagement.
Committed to Supporting Global Pharmaceutical Hubs
This shipment reinforces Vedax Pharma Mach’s growing footprint across Latin American pharmaceutical manufacturing clusters, complementing our active installations across the United States, Europe, and the Middle East.
Frequently Asked Questions (FAQs)
Q1. What format tooling was included in the Brazilian pharmaceutical shipment?
The shipment comprised an eight-machine turnkey format set including sanitary infeed worms (scrolls), bottle guide rails, central starwheels, discharge guide shoes, and dosing needle holding blocks engineered for 2 ml, 10 ml, and 20 ml aseptic vials.
Q2. How does Vedax comply with ANVISA (RDC 301/2019) standards for format tooling?
Our format tooling adheres strictly to ANVISA RDC 301/2019 cGMP standards by utilizing crevice-free geometries, electropolished fluid contact surfaces (Ra ≤ 0.2 μm), FDA 21 CFR compliant engineering polymers, and non-shedding self-lubricating materials to eliminate cross-contamination risks.
Q3. How is Factory Acceptance Testing (FAT) conducted for international export orders?
For international clients unable to attend in person, we provide live interactive 4K video FAT sessions. We test the tooling using the customer’s exact container samples at full operational speed, measuring pocket clearance, container stability, and rapid changeover performance in real-time.
Q4. Does Vedax provide international installation assistance and warranty for overseas clients?
Yes. Every international order includes detailed 3D step-by-step installation manuals, remote augmented reality (AR) video engineering support, a comprehensive 12-month mechanical warranty, and priority global express dispatch for spare components.