Inpac Medizintechnik GmbH

Gewerbestr. 34 , 75217 Birkenfeld
Germany

Telephone +49 7082 9457-0
Fax +49 7082 9457-78
info@inpac-medizintechnik.de

Trade fair hall

  • Hall 8a / J31
 Interactive Plan

Hall map

COMPAMED 2016 hall map (Hall 8a): stand J31

Fairground map

COMPAMED 2016 fairground map: Hall 8a

Our range of products

Product categories

  • 11  Manufacturing Services
  • 11.16  Forming
  • 11.16.13  Assembly

Assembly

  • 11  Manufacturing Services
  • 11.16  Forming
  • 11.16.30  Sterilisation services

Sterilisation services

  • 11  Manufacturing Services
  • 11.16  Forming
  • 11.16.31  Sterilisation validation

Sterilisation validation

  • 11  Manufacturing Services
  • 11.16  Forming
  • 11.16.32  Thermoforming

Thermoforming

  • 11  Manufacturing Services
  • 11.16  Forming
  • 11.16.33  Ultrasonic cleaning

Ultrasonic cleaning

  • 12  Packaging and print
  • 12.02  Packaging materials
  • 12.02.05  Sachets

Sachets

  • 12  Packaging and print
  • 12.02  Packaging materials
  • 12.02.07  Blister packaging, blister trays

Blister packaging, blister trays

  • 12  Packaging and print
  • 12.02  Packaging materials
  • 12.02.09  Moisture barrier packaging

Moisture barrier packaging

  • 12  Packaging and print
  • 12.02  Packaging materials
  • 12.02.12  Implant packaging

Implant packaging

  • 12  Packaging and print
  • 12.02  Packaging materials
  • 12.02.21  Barrier packaging

Barrier packaging

  • 12  Packaging and print
  • 12.02  Packaging materials
  • 12.02.22  Diecut lids

Diecut lids

  • 12  Packaging and print
  • 12.02  Packaging materials
  • 12.02.23  Sterile packaging

Sterile packaging

  • 12  Packaging and print
  • 12.02  Packaging materials
  • 12.02.33  Premade packs, others

Premade packs, others

  • 12  Packaging and print
  • 12.03  Packaging services
  • 12.03.02  Packaging design

Packaging design

  • 12  Packaging and print
  • 12.03  Packaging services
  • 12.03.04  Multi-packaging

Multi-packaging

  • 12  Packaging and print
  • 12.03  Packaging services
  • 12.03.05  Thermo forming

Thermo forming

Our products

Product category: Assembly

assembly

YOU WON'T HEAR "THAT'S IMPOSSIBLE" FROM US
COMPLETE PROCESSES FROM ONE SOURCE
We are specializing in the assembly of complex medical products, are able to adjust to the individual requirements of our customers and to offer competitive prices.

Especially if the parts of the product have to be cleaned, it is reasonable to put the entire production in our hands.

If desired, we can also take over the procurement, disposition and storage of components.
inpac's wide net of suppliers comprises companies experienced in the medical device sector like injection molders and metal surface refiners. We ensure a hygienically proper course and avoid interface problems as well as unnecessary transports.

Prior to producing a product, our employees undergo a comprehensive training.
Our knowledge in development, production and quality assurance guarantee even the assembly of complex products at highest quality standards.

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Product category: Sterilisation services

cleaning

YOUR SAFETY IS RELEVANT FOR US
CLEANING METHODS THAT PERFECTLY SUIT YOUR DEMANDS
cleaning disinfection
ultrasonic cleaning
plasma cleaning
cleaning validation

Medical products must have and keep a defined cleaning condition. The aim of the cleaning is the depletion of the bioburden, of the particulate and chemical load. Therefore, our experts develop individualized cleaning strategies together with the customer. We analyze pre-processes with regard to potential contaminations. According to the product features, cleaning methods are developed that meet the normative and legal requirements to a medical product. We have many years of experience in the areas microbiology, material properties, and production processes – and, thus, can offer optimum support to our customers.

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Product category: Sterilisation services

sterilization

SENT TO THE CUSTOMER IN ASEPTICAL PACKAGES
STANDARDIZED METHODS FOR YOUR PRODUCTS
radiation (beta and gamma)
gas (ethylene oxide)
steam
collaboration with certified sterilization companies
planning and implementation of the validations
sterilization certificates of the batches
surveyed by independent accredited laboratories
In collaboration with certified sterilization companies, each product is
sterilized according to validated methods. The processes are implemented
in accordance with the international standards ISO 11137 (sterilization with
radiation) and ISO 11135 (sterilization with gas). We document the validation
and prepare a sterilization certificate for each individual batch. The vali-
dation of production processes and the materials used always relate to the
specific product of our customers. As a basic principle, all production means
used by us are qualified.

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Product category: Sterilisation validation

validation

WE VALIDATE ALL PROCESS SEQUENCES
PACKAGING, CLEANING, STERILIZATION, TRANSPORT, AND DURABILITY
cleaning validation
sterilization validation
packaging validation
accelerated / real-time aging
simulation of transport
accredited laboratories

A medical product – safely produced and sterile:
To achieve this, all processes from cleaning via packaging up to sterilization and transport must be arranged in a way that they deliver impeccable results. Therefore, our processes pass throughcomprehensive normative examinations that we always confirm statistically.
At inpac, the validation issue starts with the cleaning process. At first, we analyze the condition of the product at the time of delivery. "Worst-case" conditions for the pre-processes are determined together with the manufacturer. These "worst-case" conditions are used to define a customized cleaning process. Only then the cleaning validation takes place which is applied to prove by ISO standards and pharmacopoeia that a clean product is the result even after an unfavorable process run and under "worst-case" conditions at the time of delivery.
The same applies to the packaging processes. As soon as a packaging system has been designed for the product, we determine the parameters for the process on the basis of thestandard series ISO 11607. Process fluctuations as well as machine tolerances are considered when determining the upper and lower limits of the future process window. There, we pay attention to stability and homogeneity of the sterile barrier where its integrity is proved by dye test (ASTM F1929), burst test (ASTM
F1140), and germ barrier test (ISO 11607). Our employees determine the weakest point and that's exactly where they conduct comprehensive, statistically confirmed examinations. We consider all factors that might have an influence on the stability, durability and homogeneity of the sterile barrier. In doing so, mainly the following processes are concerned:
sterilization procedure
transport processes
storage and aging processes

For the validation of the sterilization processes, we apply the same philosophy. The practical procedure is amply standardized by harmonized standard specifications. For the sterilization with gamma rays, the standard series ISO 11137 apply where – basing on a constant bioburden and, thus, on a controlled production process – the product achieves a sterility assurance level (SAL) of 10-6. Well-defined specifications prove that the packaging order determined by the dose distribution mapping ensures an optimum radiation of the products.

For the sterilization with ethylene oxide gas, the standard series ISO 11135 apply. The implemented "overkill method" guarantees that at least 106 germs are eliminated. We furnish proof of this sterilization process by means of half-cycles in the scope of the validation. In conclusion, we conduct a residual gas determination according to ISO 10993-7 revealing that the thresholds for EO and ECH go significantly below the limits and therefore produce proof that the product sterilized with EO can be used safely.

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Product category: Packaging design

packaging

EVERYTHING IS PROPERLY PACKED
FROM THE POUCH TO THE BLISTER
development of individual packaging solutions in a 3-D CAD model
symbiosis of technique, esthetics, and user aspects
spectroscopic characterization of the packing materials
state-of-the-art high-quality machines and plants with validated processes
pouches from in-house production | triple-edge chevron pouches
in-line pouch packaging
hard blisters from in-house production
hard blisters on in-line machines
soft blisters
form fill seal machines
label printing, flexo printing, thermotransfer printing
manual cardboard packaging, cartoner
validation of the packaging processes
accelerated and real-time aging as well as control of the sterile barriers
simulation of transport
We offer in-house production of all common packaging types for medical products,
e.g. hard and soft blisters as well as outer packagings. Different processes are used
for the labelling of the products in order to meet the standard requirements. As a
matter of course, we validate the packaging process and provide evidence for the
maintenance of sterility. We examine the sterile barriers of the products after
accelerated and real-time aging and simulate the transport situations in accordance
with international standards in order to ensure sterility and, thus, durability of the
product until needed for use.

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About us

Company details

The inpac Medizintechnik GmbH was established in

July 2003 in Birkenfeld/Germany (near Pforzheim).

We built our production facilities in accordance with

the latest GMP standards and state of the art. Extensive

clean room capacities of ISO class 7 and class 8 are

available; if required, we can also provide higher

classes.

 

In October 2003, our company was certified by the

DEKRA-ITS Certification Services according to EN ISO 9001/12.2000 and to EN ISO 13485/07.2003

 

Our employees exclusively come from the medical

device industry and gathered extensive experience in

development, production, and quality assurance, some

of them even had leading positions there.

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Company data

Sales volume

10-49 Mio US $

Export content

max. 25%

Number of employees

100-499

Foundation

2003

Area of business

Services