Hpm™ One Solution

One Solution consists of eight different elements and, just as the title says, One Solution.
Our aim is to offer the most sustainable and efficient solutions based on services and competences in:

• Quality/Regulatory
• Manufacturing
• Product development
• Assembly/Packaging
• Project process
• Sustainability
• Sourcing 
• and Logistics for polymer products within Life Science. 

• Registration of medical devices according to the MDR. We handle products that meet the MDR requirements from class I-III products 
• We handle technical documentation for class I-III products 
• We perform validation of various processes according to an agreed process validation plan. Process validations are carried out in connection with injection molding, blow molding, ultrasonic welding, assembly, bag sealing (sterile barrier). 
• We are certified according to ISO 9001 and ISO 13485

Examples of process validation we perform: 

1. Installation Qualification (IQ)
This protocol ensures that the system/equipment and its components are installed correctly and to the original manufacturer’s specifications. 
Calibration of major equipment, accessory equipment, and/or utilities should be performed in this step as well.
2. Operational Qualifcation (OQ)
This step proceeds after the IQ has been performed. In the OQ, the process window is tested and challenged.
3. Performance Qualification (PQ)
This phase tests the ability of the process to perform over long periods of time within tolerance deemed acceptable.
PQ is performed on the manufacturing process overall. Individual components of the system are not tested individually.
4. Validation Report (VR)
   
Validation report is prepared and presented to the customer.
Written consent from the customer/Quality Department releases products for delivery.

We have several different manufacturing techniques to be able to deliver the perfect detail. 
We produce medical devices in production premises and clean rooms classified according to ISO 14644-1 in class 8 using the following manufacturing techniques:
Injection molding our injection molding machines have a capacity of 30 to 320 tons. The machines are electric and most of our machines are placed in class 8 cleanrooms.
Our ambition is to be the natural choice when it comes to injection molding of complex and demanding details. We can make both long and short runs and we are proud being
able to deliver high quality parts quickly and reliably.
Thermoforming the most cost-effective solution for thin-walled products in large volumes
Injection blow molding a combined process of injection molding and blow molding for products that require high precision while blow molding technology is a requirement.
In volumes up to 1 liter.
Blow molding our blow molding machines produce parts that, among other things,consist of a hollow body and thus cannot be injection molded in volumes up to 1 liter.
Automation cost effective solutions for small, medium and high-volume products

Product development

We provide:

• CAD drawings (SolidWorks & AutoCAD)
• Form fill analysis
• Tool simulation
• We provide prototyping tools as well as manufacturing and evaluation of prototypes. This gives us an excellent opportunity to check both design and function at an early stage.
• The prototypes also provide important information that helps us design tools with maximum efficiency and quality.
• At an early stage of the project, prototypes can be crucial in determining the design of the product.
• Tool construction
• The product development process is carried out with regard to social and moral aspects as well as the least possible climate impact.
• Fossilfree material selection
• Included system components (including packaging material)

Assembly & packaging

Assembly

• Automatic and manual assembly in Bredaryd and Tallinn. We assemble in ISO 146441 class 8 clean rooms.

• Many assemblies require merging by gluing. Most of our materials can be merged with glue. We use both conventional and UV gluing
• Ultrasonic welding, merging technology that utilizes the material's own properties.

• We manufacture, assemble and package according to the customer's wishes before the details are distributed.

• We offer cleaning of medical device components and products not manufactured in a controlled environment. This is most often necessary to decrease number of particles and bioburden.
  The cleaning process is most often performed in the following steps:
• Presoaking
• Ultrasonic cleaning
• Rinsing
• Disinfection

• ETO Ethylene Oxide
• EBeam steralization
• Gamma steralization
• Gasplasma steralization

• Single colour printing
• Multi color printing
• Single or 2-component ink

1. Request
2. Preliminary project - Quote 
3. Project planning - Time schedule 
4. Project realization 
5. Project completion

Sustainability

Our vision requires us to support a transformation towards a more sustainable society.
Our main goal to reduce our carbon footprint is to increase production and sales of products made from fossil-free raw materials.

• We are certified according to ISO 14001
• We are ISCC certified and manufacture products in fossilfree material according to the mass balance principle
• We participate in several projects around the development of circular solutions
• Regional sourcing means advantages regarding freight, lower environmental impact, lead times, delivery security, stable production, high social and moral aspects 
• We use FSC-labelled packaging

Sourcing

We focus on regional sourcing with manufacturing in Sweden, local purchase of included materials, components and tools, which means:

• lower shipping costs
• lower environmental impact
• shorter lead times
• higher delivery security
• increased stability in production

Customer requirements and our production flows place high demands on internal planning and place high demands on internal and external logistics.

• We optimize flows within the process from manufacturing to delivery
• Complies with the regulatory requirements according to the MDR for medical devices
• Optimizes packaging to create efficient handling internally and externally
• Offers 3PL with goods receipt, arrival control, registration, warehousing, pick and pack, transport document management, customs clearance and shipping
• VMI supplier controlled warehouses
• We also offer customer specific logistics solutions