hk packaging

Before your pharma packaging project

Can’t see the wood for the trees

technical-support
quality-management
trainings

Solutions

Team up with HK Packaging 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.

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 & Regulator 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 playing guitar in a rock band. That’s me.
It is challenging but also rewarding. A good band is a good team, going even better with each band practice and each new song. So, one guy alone doesn’t make a band. You need some friends to “rock” and improve. That’s exactly the same for a consultant.

GET STARTED

I need you to make it work.

Let’s rock together and beside hard work we will have some fun as well.

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

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.

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

Swiss Medic Delegate for EDQM WG16 (Pharm Eu. Chapter 3. Plastics)

PDA James P. Agalloco Award for Excellence in Education; March 2019

Customers served since 2015: ~70 companies

(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.

gallery-about
gallery-about
gallery-about
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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 Requirements Specification 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 for silicone rubber manufacturer (Hearing Devices)
  • ISO 15378 certification for PFS 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 SyringesOphthamological Syringes
  • PFS components and drug filled PFS

Validation Support and Submission Documents (DMF, CTD)

  • Polymer PFS and Containers
  • Glass PFS and 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
PDA Band

See the latest update of the PDA-Europe Band. Let’s Rock …

We are really looking forward to entertain you “live” as soon as possible at one of the famous social event at the PDA events.

blog
Events

I might not always have an own booth but I should be easy to spot hanging around at others

Due to the Pandemic most conferences are cancelled as  “live events”, so please look around as we get back into action in 2022

blog
Trainings & Workshops

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

See me speak at: October 7th and 8th Post Conference Training: Test Method for Pre-Filled Syringes at PDA’s...

blog
PDA Band

See the latest update of the PDA-Europe Band. Let’s Rock …

We are really looking forward to entertain you “live” as soon as possible at one of the famous social event at the PDA events.

blog
Events

I might not always have an own booth but I should be easy to spot hanging around at others

Due to the Pandemic most conferences are cancelled as  “live events”, so please look around as we get back into action in 2022

blog
Trainings & Workshops

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

See me speak at: October 7th and 8th Post Conference Training: Test Method for Pre-Filled Syringes at PDA’s...