hk packaging

Before your pharma packaging project

Can’t see the wood for the trees ...

technical-support
quality-management
trainings

Consulting

... Team up with HK Packaging Consulting and together we find a clear and structured path to solve your problem

HK Packaging Consulting GmbH is a Swiss based technical and regulatory consultancy providing customized and hands-on assistance to the pharmaceutical and biotechnical industry as well as for manufacturers of medical devices. Founded in 2015 the company is based in Uznach / Switzerland.

The company core competencies are within the development and manufacturing of primary and secondary packaging systems as well as medical devices. At HK Packaging Consulting you always will be served by the Boss himself.

Technical Support

Technical support

  • Primary Packaging Material Expertise (plastic / glass)
  • Components and Accessories for Container Closure Systems (CCS)
  • Establish Scientific Evidence for CCS
  • Manufacturing Processes: Molding, Fill-Finish
  • Trouble Shooting
Technical Support

Quality & Regulatory support

  • Preparation for ISO 15378, 13485 Certification
  • DMF, CTD Documentation
  • Customer Audits
Technical Support

Education

  • Customized Inhouse Trainings for CCS
  • Workshops for Development and Test Methods for CCS

Active regions of HK Packaging Consulting

  • usa USA
  • usaEUROPE
  • usaSOUTH KOREA
  • usaINDIA
  • usaTURKEY

Working principles

Quality

Quality of work and service is key! It always needs to be spot on.

End of discussion!

Relationships

A customer / consultant relationship is based on trust, loyality and communication. It is important to listen to the customer, understand his needs and then take ownership to help to fix the problem. That is what I myself would like to expect from a consultant and that is why you will get it that way.

Authenticity

I am Bavarian so that’s why I prefer beer over wine. I don’t wear a suit and tie and my customers might raise an eyebrow when they have a first look at me. But I am a professional at work. And by the way, I have some returning customers, so it might not be too bad after all. Now, if you continue to scroll down further there should be no surprises anymore.

About me

Hi, I am Horst, the CEO of HK Packaging Consulting GmbH based in Uznach, Switzerland.

about

I founded the company in 2015 and I do offer technical and regulatory consultancy all around Primary Packaging and Container Closure Systems. I have over 25 years of industry experience and that covers development, manufacturing, regulatory and quality management of primary packaging systems especially for syringes made of plastic and glass. That also allows me to give customized inhouse trainings depending on your needs.

guitar

I do have extensive knowledge in the development, manufacturing and quality management of primary packaging systems especially for syringe systems made out of plastic and glass, including the regulatory requirements for raw materials and finished product.

I am an active Member of ISO TC 84 Devices for administration of medicinal products and catheters

  • WG 3 Needle based injection systems – Injectors, containers, needles
  • WG 11 Syringes
  • WG 13 On-body delivery systems
  • WG 15 Device Change Management

and ISO TC 76: Transfusion, infusion an injection, and blood processing equipment for medical and pharmaceutical use

  • WG 2 Rigid container system and related accessories for parenterals and injectables (Convenor: Horst Koller)
  • WG 4 Elastomeric parts and components and related secondary packaging

Also, I am a Swiss Medic Delegate for EDQM WG16 (Pharm Eu. Chapter 3. Plastics)

I did receive the PDA James P. Agalloco Award for Excellence in Education; March 2019

Up to now I’ve served > 80 customers.

(Big Pharma, Start Ups, Device Manufacturer, Component Manufacturer, Primary Packaging Manufacturer)

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Let's Rock

I am playing guitar in a rock band. It is challenging but also rewarding. A good band is a good team, going even better with each band practice. So, one guy alone doesn’t make a band. You need some friends to “rock” and improve.

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Projects

Since confidentiality is key for my business, you will understand that I will not show any names of my customers but rather let you know some of my projects I did work on and still might do.

  • Choice of Container Material and Components (vials, syringes, cartridges)
  • Fill / Finishing Support
  • Test Matrix for Compendial Compliance Testing and E&L Strategies
  • Submission Support (DMF / 510k)
  • Design Control Process Implementation
  • ISO 15378 certification / GMP Requirements
  • Container Compliance and Container Performance Requirements and Test Matrix
  • Technical and Regulatory Requirement Specifications for PFS components
  • Combination Products (Glass and Polymer Syringes)
  • Optimization of Rubber Formulation for Syringes in Use with Autoinjectors and PFS for manual use
  • Second source project for vial stopper
  • Test Matrix for Functional and CCI Testing
  • ISO 13485 certification support for silicone rubber manufacturer (Hearing Devices)
  • ISO 15378 certification support for PFS Systems and components for Delivery Devices
  • URS / Test Matrix / Risk Analyses
  • Compendial and Compliance Testing (Pharmacopeias / ISO)
  • Sterilization Validation Support
  • Large Volume Plastic Infusion Bottles
  • Ophthamological PFS
  • PFS components and drug filled PFS
  • Validation Support and Submission Documents (DMF, CTD)
  • PFS Systems and RTU-Containers

Blog posts

If you made it down to this section you can also spend a few minutes and have a look where you might see me giving an educational lesson, where I might hang around at conferences or see our latest news about the Band \m/

blog
Trainings & Workshops

Here is where you find information about trainings and workshops I am participating set up by seminar organizers.

See me train at: PDA TRAINING COURSE: 08:30 - 16:00 PDA-546.1 Understanding container options and user needs for syringes, cart...

blog
Trainings & Workshops

Here is where you find information about trainings and workshops I am participating set up by seminar organizers.

See me train at: PDA TRAINING COURSE: 08:30 - 16:00 PDA-546.1 Understanding container options and user needs for syringes, cart...