Medical

Rethinking Pharma Packaging – for Cleanroom, Compliance, and Control.

Pharmaceutical and Medical Packaging

In Pharmaceutical Packaging, there’s no Room for Compromise – Hygiene, Repeatability and Validation are Paramount.

Kautex extrusion blow molding systems are built to meet exactly these demands. Our all-electric platforms with stainless-steel cladding, sealed drive units, and laminar flow-optimized machine architecture are engineered for cleanroom applications up to ISO Class 7.

With decades of experience in wall-thickness control, multilayer co-extrusion, and repeatable processing, we enable efficient production of dropper bottles, unit-dose containers, vials, and medical-grade packaging. Whether it’s primary pharma packaging or functional medical housing – our systems are fully validatable and ready for FDA/GMP-compliant production.

Key features such as in-line camera inspection, automated deflashing and take-out, weight checks, and batch traceability can be seamlessly integrated – supported by our digital process tools and downstream solutions. Our SKYREEF GREEN platform can even operate as a closed system – with minimal particle exposure and maximum energy efficiency.

Pharma requires more than precision – it demands trust.
With Kautex, you get reproducible cleanroom performance tailored to your compliance and production goals.

Your Benefits with Kautex

Your Benefits with Kautex Medical and Pharmaceutical Packaging Solutions for Safe, Reliable and Compliant Production.

Cleanroom-ready by design

Fully enclosed machine concepts with stainless cladding, sealed drives, and ISO 7-ready layouts – ensuring hygiene compliance without costly retrofits.

Validated processes – digitally managed

BC6 control system with audit trails, recipe libraries, and user hierarchies – compliant with CFR21-Part11 and GMP documentation requirements.

Production-grade precision

Servo-driven parison control, repeatable blowing processes, and tailor-made tooling – for pharmaceutical articles with accurate dosing behavior.

Seamless downstream integration

Plug-and-play interfaces for leak testers, vision systems, weight cells – traceable via MES/ERP and easy to validate.

Future-ready platforms

Modular SKYREEF and KBB series compatible with bio-polymers, recyclates, barrier materials, and new-generation medical articles.

Technology Focus

Clean Room Production.

Clean Room Production

Cleanliness starts with the machine. For pharmaceutical and medical applications, Kautex has developed fully electric extrusion blow molding solutions specifically engineered for cleanroom integration. Our SKYREEF GREEN platform enables product-safe production up to ISO Class 7, featuring stainless steel cladding, sealed drives, and hygienically optimized geometry.

The machine layout supports vertical laminar flow management to effectively control particulate emissions. All media lines are encapsulated, cooling circuits are physically separated, and dead zones are eliminated. Controls, HMI, and peripherals can be externally mounted or hermetically isolated from the cleanroom.

Downstream quality assurance is GMP-compliant through our Intelligate system, which supports in-line leak testing, camera inspection, weight verification, and UV barrier checks. Combined with validated recipe management (BC6), digital audit trails, and remote monitoring, Kautex delivers a closed-loop solution for reliable, traceable, and fully validatable cleanroom production.

Medical Know-How

Pharmaceutical packaging must be functional, reliable, and hygienically flawless. At the same time, the demands for smart design, precise dosing, and material efficiency continue to grow. Kautex delivers solutions that meet all of these needs – with process-driven article engineering and a deep understanding of medical-grade packaging.

Typical Applications:

  • Dropper bottles and vials for ophthalmic, nasal, or injectable use
  • Single-dose containers with squeeze or twist-off features
  • Infusion bottles with sterilizable, high-volume geometries
  • Multilayer containers with EVOH or PA barrier structures
  • Specialized housings for inhalers or medical sensors

Kautex Advantages:

With optimized wall-thickness control, servo-driven parison programming, and in-house simulation know-how, we enable uniform part quality – even for tilted necks or asymmetrical designs. Our systems support LDPE, HDPE, PP, and pharma-grade specialty polymers – including compatibility with in-mold labeling or laser marking.

Whether you’re developing a prototype in our Technikum or scaling a validated production line – Kautex helps you deliver pharmaceutical articles that meet regulatory expectations and perform reliably in everyday use.

Our Machines
for your Production

Dedicated Machines enabling you to produce for the Medical and Pharmaceutical Industry.
Proven. Flexible. Compact.

The KEB Green delivers maximum flexibility for small bottles to lager containers. Versatile, reliable, and efficient – with in-line clamping, fast mold changes, and integrated deflashing for streamlined production.

Efficient. Adaptive- Future-Ready.​

The Skyreef series offers flexible, modular machines for bottles and jerry cans up to 20 L. Efficient, adaptable, and future-ready – Green with all-electric motion, fast color changes, and automatic mold thickness compensation.

High-Tec. High-Speed. High-Output.

The KBB series delivers high-performance packaging for consumer, pharmaceutical, specializing in bottles. Full electrical drives and advanced technology ensures reliable, efficient production with outstanding quality.

Your direct contact

Discover your options right now and contact our Experts.

Karola Hepfner Kautex Mechanical Engineering

Karola Hepfner

General Manager Sales

Christmas break announcement!

Dear valued customers, please be informed that Kautex Maschinenbau System GmbH (only Bonn location!) will have a Christmas break starting on December 24nd. We will be back at January 5th 2026.
 
An emergency service team will be available under +49 228 929 390 14.