FDA 21 CFR · EMA GMP · ISO 13485 Certified

Precision Machinery for Life-Critical Manufacturing.

From vial filling to final packaging — our GMP-certified machinery helps pharmaceutical and medical device manufacturers achieve maximum output, compliance, and reproducibility at every production stage.

Explore Our Machines → ▷ Watch a Live Process Demo

Trusted by 340+ pharmaceutical manufacturers in 42 countries

LIVE VALIDATION DATA
Output 36,000 u/hr
Rejection 0.003%
Uptime 99.6%
Status ✓ cGMP
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WHAT DO YOU MANUFACTURE?

Find your machine
by application.

← Scroll to explore all applications →
Injectable & Parenterals
Vials, syringes, cartridges — aseptic and GMP-compliant
14 machines →
Oral Solid Dose
Tablets, capsules, sachets — high-speed, validated
11 machines →
Biologics & Aseptic
Biosimilars, mAbs, cell therapies
8 machines →
Ophthalmic & Nasal
Eye drops, nasal sprays, sterile liquids
6 machines →
Blister & Secondary Packaging
Blister, strip, carton, serialization
9 machines →
Medical Device Assembly
Device packaging, combination products
7 machines →
42+
Countries
Machines installed worldwide
340+
Manufacturers
Pharmaceutical clients
99.6%
Uptime SLA
Average machine uptime
100%
Compliance Rate
FDA/EMA audit pass rate
35+
Years
Of GMP engineering

MACHINERY

Built for precision.
Certified for compliance.

Each machine designed, validated, and documented to meet the world's most demanding pharmaceutical manufacturing regulations.

View all products →
● VIEW 3D MODEL
SHREDDER BELT DRIVE ESC
VIZ 1300
High Performance Single-Shaft Shredder
Motor power: 75 – 90 kW
Rotor: 1,245 mm × ⌀495 mm
VSC.connect remote monitoring
9.3 t · 4,080 mm View 3D Model →
● VIEW 3D MODEL
RDF SHREDDER HITORCH DIRECT
VEZ 2500 TV
RDF Shredder — Direct Drive HiTorc
Motor power: 155 kW
Rotor: 2,500 mm × ⌀800 mm
VSC.connect remote monitoring
28 t · 2,770 mm View 3D Model →
Blister Packaging Machine BLP-200S
PACKAGING
Blister Packaging Machine
Series BLP-200S — Multi-Format Blister Line
Speed: 200 blisters/min
Formats: PVC/ALU/PVDC/COC
Standards: IPC · CE
CE · IPC View Specifications →
Automated Visual Inspection AVI-Vision
INSPECTION AI-POWERED
Automated Visual Inspection
Series AVI-Vision — AI-Driven Defect Detection
Defect detection <0.2mm
AI vision engine onboard
21 CFR Part 11 audit trail
21 CFR Pt.11 View Specifications →
Lyophilization Freeze-Drying System LYO-Pro
BIOLOGICS
Lyophilization / Freeze-Drying System
Series LYO-Pro — Aseptic Lyophilizer
Chamber: 5–200 m²
Aseptic loading/unloading
cGMP documentation package
FDA · EMA View Specifications →

ENGINEERING INSIGHT

Inside the machine.

Click any component to explore the engineering behind our compliance-by-design philosophy.

◈ Select a component

Use the legend below or click directly on the 3D machine to explore each system.

1
Isolator Barrier System
2
Servo-Driven Filling System
3
CIP/SIP Automated Cleaning
4
21 CFR Part 11 HMI

REGULATORY COMPLIANCE

"Every machine. Every market. Every audit."

Our machines are designed with compliance as a core engineering requirement — not an afterthought.

FDA
21 CFR

FDA 21 CFR Parts 210/211

Current Good Manufacturing Practice for Finished Pharmaceuticals — full documentation package supplied.

Issuing: U.S. Food & Drug Administration · Scope: All markets ↓ Download Certificate PDF
EU GMP
AX1

EU GMP Annex 1 (2022 Revision)

Manufacture of Sterile Medicinal Products — latest revision, fully implemented in all aseptic equipment.

Issuing: European Medicines Agency · Scope: EU markets ↓ Download Certificate PDF
ISO
13485

ISO 13485:2016

Medical Devices Quality Management System — demonstrates sustained capability to provide compliant medical devices.

Issuing: ISO/TÜV · Scope: Medical device manufacturing ↓ Download Certificate PDF
ISO
9001

ISO 9001:2015

Quality Management System — full operations, from design and manufacturing through delivery and after-sales.

Issuing: ISO · Scope: Full company operations ↓ Download Certificate PDF
CE
MARK

CE Marking

EU Machinery Directive 2006/42/EC conformity — all machines supplied with Declaration of Conformity.

Issuing: Notified Body · Scope: EU machinery directive ↓ Download Certificate PDF
21 CFR
Pt.11

21 CFR Part 11

Electronic Records & Electronic Signatures — full audit trail, e-signature, and SCADA integration as standard.

Issuing: FDA · Scope: All digital/HMI systems ↓ Download Certificate PDF
"All machinery is supplied with a complete Validation Master Plan, FAT/SAT protocols, IQ/OQ documentation package, and 21 CFR Part 11 compliant audit trail as standard."

Local support. Global compliance.

42 COUNTRIES · 11 DIRECT OFFICES · 31 CERTIFIED DISTRIBUTORS

🇩🇪
Germany
Headquarters
🇺🇸
United States
Philadelphia, PA
🇬🇧
United Kingdom
Manchester
🇨🇭
Switzerland
Basel
🇫🇷
France
Lyon
🇯🇵
Japan
Osaka · Opening 2025
🇮🇳
India
Mumbai
🌍
+31 Partners
Certified distributors

CASE STUDIES

"Proven in production."

FACILITY VISUAL · AVF-400 INSTALLATION

INJECTABLE · ASEPTIC FILLING · CMO

"Our AVF-400 filling line achieved first-batch success with zero FDA observations on its very first inspection."

— Head of Operations, Leading European CMO, France

400 vials/min EU GMP Annex 1 France · 2024 Zero FDA Observations
Read Full Case Study → ↓ Download PDF

BIOLOGICS · LYOPHILIZATION · SWITZERLAND

Biologic Drug Manufacturer, Basel

LYO-Pro lyophilization system, 80 m² aseptic chamber with automated loading/unloading. FDA and EMA dual-dossier compliant.

80 m² Chamber FDA + EMA 1st-pass validation
View Machine →

SOLID DOSE · TABLET · INDIA

Generic Tablet Manufacturer, Hyderabad

High-speed tablet press + blister packaging line. Output: 1.2M tablets/day. Machines: RTP-36D + BLP-200S in tandem line.

1.2M tabs/day WHO GMP On-time delivery
View Machine →