Packaging of medical and pharmaceutical products

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Content

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What we stand for 4-5

Our services 6-9

Packaging solutions for:

• Sterile medical supplies

• Pharmaceuticals and biopharmaceuticals

• Diagnostic products

• Clinical research packs

Our areas of expertise 10-11

• Innovative and customized packaging solutions

Our portfolio

• Thermoformers 12-13

• Traysealers 14-15

• Chamber machines 14-15

• Automation 16-17

• Inspection modules 18-19

• Labeling solutions 20- 21

Line concepts 22-23

Complete lines from a single source

Our support services 24-25

• Validation

• Calibration

• FDA 21 CFR Part 11

• Project management

• Training

Multivac, a global player 26-27

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What we stand for

Quality generates trust

Your products are as sensitive as human life itself, and this creates

a particular challenge when it comes to packaging them. As a global

company with a wealth of experience going back many years, Multivac

gives you the certainty of knowing that your medical and pharmaceutical

products are in the best of hands. The packaging solution we offer you

is far more than just a machine.

Our process starts with listening to you and developing the deepest

possible understanding of the specific requirements of your medical and

pharmaceutical products. Your stipulations and our expertise culminate

in a tailor-made solution which delivers a reliable packaging process.

We work alongside you throughout the project – from initial consultation

and implementation of your requirements to commissioning of the machine

and beyond. Our unique lifecycle service ensures that you get the very best,

personalized service for your machine throughout its long service life.

Enjoy the benefits of our superlative quality standards. Our efficient

machines incorporate ground-breaking technology, combining functionality

with reproducible processes. Our experienced team of experts guarantees

that every product you pack is backed up by over 300 advisors and 500

service technicians worldwide.

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Packaging solutions for sterile medical supplies

The primary imperative: protecting sterility.

The sterility of your products is an absolute prerequisite. Our solutions

guarantee you a reliable, reproducible and traceable packaging process.

Implants, catheters, stents and other medical supplies are fully protected

during transportation and storage until they are used. Multivac packaging

machines are designed to handle a range of packaging materials, including

gas-permeable materials, leaving you free to choose your preferred method

of sterilization.

Our services

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Packaging solutions for pharmaceuticals and biopharmaceuticals

Mechanical protection

Your ampoules, vials and syringes contain highly

sensitive medicaments. We help to ensure that

your products reach the patient safely

and intact, whether you are producing

packaging for a single product or a

multipack. In addition to our proven, high-

quality standard packaging concepts, we

also develop custom solutions based on your

individual requirements. Whatever you need,

we can offer expert and comprehensive advice.

After all, pharmaceutical packaging is a matter of

trust.

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Packaging solutions for diagnostic products

Reaching the customer safely

Correct diagnoses rely on accurate measuring instruments.

In many cases just a slight variance from the normal values

can mean the difference between healthy and sick. As

a manufacturer, you guarantee the reliability of

your diagnostic products. As a

packaging specialist, we ensure

that your products reach

your customers safely.

We work with you to

identify the critical para-

meters and develop safe

packaging solutions for

individual products, multi-

component products and

diagnostic kits.

Packaging solutions for clinical research packs

A high degree of individualization

Clinical trials are a vital stage in the development and approval of new

products. Our packaging solutions allow a high degree of individualization

in terms of pack content and labeling, so that medical research remains

scientific. Individualization is easily achieved with our packaging solutions,

for both large and small production batches.

And, of course, our packaging solution

also includes documentation and data

capture of the pack content.

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BETTER PACKAGING

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Our areas of expertise

Innovative and customized packaging solutions

Innovative technologies are a matter of course to us. We‘ve been leading

the way for years when it comes to optimizing packaging processes.

Packaging design

By talking to our customers, we turn complex product requirements into

full-fledged package designs. We then produce sample packs, which we put

through a whole range of tests. We do this in our own laboratory, which is

fully equipped with a range of measuring equipment.

Opening aids

In life-threatening situations, it is vital to be able to open packages quickly

and safely. Multivac machines are designed to produce packaging with a

wide variety of opening aids appropriate to the use of the individual product.

They include thumb holes, finger holes, peel-off tabs, peel-off corners, and

chevron seals.

Material development

In our application center we are constantly developing new solutions to

improve the efficiency of packaging material usage. We can help you

to analyze and choose new packaging materials and to create the most

challenging pack shapes.

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Machine technology at the highest level

Whether you opt for a stand-alone or integrated model our packaging

solutions are thoroughly tried and tested. Multivac packaging solutions

offer efficiency, process reliability and reproducibility. Of course, Multivac

machines can handle a wide range of materials, including mono- and

multilayer films, paper and nonwoven fabrics, and aluminium composites.

ThermoformersMultivac thermoformers form, fill and seal all types of packaging materials

and pack under vacuum or a protective atmosphere. Depending on your

production volume, we can provide machines in all output classes.

They offer an impressive range of features:

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Our portfolio

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Forming:

• Wide choice of materials

• Variety of tried-and-tested forming and heating systems

• Excellent pack quality, even with long cut-off lengths and maximum

forming depth

Loading:

• Manual or automatic loading

Labeling:

• Integration of a wide variety of printing systems

• Modular labeling systems

Sealing:

• Secure and reproducible seals

• Verifiable process parameters (sealing temperature, pressure and time)

Cutting:

• Low-particle cutting

• Material-specific cutting systems and forms

• Perforation options

Handover to downstream processes:

Range of handling systems with sorting, orientation, handover, discharge,

quality control, and buffer functions

Control equipment:

A wide variety of control equipment can be integrated into the packaging

machine to ensure optimal packaging results.

• Contents:

Identification, presence, completeness, protrusion, etc.

• Packaging material:

Splices, pinhole detection, etc.

• Process:

Parameter monitoring

HMI:

• Simple and intuitive operation via touch display

• Comprehensive data capture and logging

• Descriptive fault diagnosis

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Traysealers

Multivac traysealers are the ideal packaging solution if you want

to produce relatively small batch sizes or use a variety of different

packaging forms and materials. Our traysealers can be used

for producing vacuum packs or modified atmosphere packs.

Traysealers are also the right choice if you want to insert

sample packs of finished or highly sensitive products

manually into the packages.

Our portfolio

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Chamber machines

Multivac chamber machines can be used for packing products like

stents into pouches made from a variety of materials. The products

can be packed under vacuum or in a modified atmosphere.

We have developed our TC (thermo controlled) series of chamber

machines specifically for packing sterile medical supplies in pouches.

These machines provide verifiable sealing operations which are

capable of validation, and make your processes even more secure:

Preparation:

Barcodes and RFID tags are used to ensure the proper identification

of the individual components and elements.

Packaging:

All of the critical process parameters such as sealing time, sealing

temperature, vacuum and gas flushing, etc. are precisely controlled

and can be verified.

Documentation:

All sequential process steps are documented from start to finish.

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Automation

Multivac handling modules help you to automate manual packaging

operations safely and economically. Their uniformly modular design

with interchangeable gripper systems allows our flexible modules

to be used with virtually all products and packaging types.

Characteristics:

• Highspeedandprecision

• Quickandeasyretooling

• Consistentcleandesign

• Compact,space-savingconstruction

Multivac handling modules can be used for a wide variety of

products and packaging types:

• Loading

• Unloading

• Buffering

• Orientation

• Ejectionandbypassfunctions

• Late-stagecustomization

• In-processcontrol

Our portfolio

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Our portfolio

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Inspection modules

For the final pack inspection process we have developed the

innovative image processing system Multivac Vision System (MVS).

With absolute accuracy, even at high speeds, the MVS handles all

detection and inspection tasks, including

• Qualityandcompletenessofthepackcontents

• Positioningandprintingofthelabel

• Presenceandlegibilityofvariableproductdata(OCV,OCR),

including barcodes, data matrix codes, batch numbers, etc.

• Packagingqualityintermsofshape,colorandsurfacefinish

• Individualpackspecifications

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Our portfolio

Labeling solutions

Package labeling helps to prevent counterfeiting and provides

full traceability throughout the logistics chain. So our portfolio

includes a number of reliable and flexible labeling and direct

printing systems:

Labeling systems

Our labeling systems allow labels to be applied to primary and

secondary packaging in almost any position. In conjunction with

MR Etikettiertechnik, a member of the Multivac group of companies,

we can offer tailor-made systems designed in house.

Direct web printing systems

Variable data such as product name, batch number, serial number,

lot number, barcodes, information on sterilization procedures, and

expiration date can be printed quickly, accurately and cleanly onto

the packaging material. Almost all commercial marking systems

can be used:

- Thermal transfer

- Flexographic printing

- Inkjet

- DOD (drop-on-demand)

- Laser

- Hot foil stamping

- etc.

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Automation and integration - line concepts from Multivac.

One of our strengths is the development of automated packaging

solutions. We can work alongside you to design fully automatic, integrated

packaging lines. Simply tell us what you need, and we will develop an

automation solution tailored exactly to your requirements. We can even

integrate systems and components from other manufacturers if necessary.

But in all cases we will ensure that the various elements fit together

perfectly. If you choose a complete line from Multivac, you benefit from

the unbeatable advantages of our packaging solutions:

• Synchronized modules and interfaces

• Reliable product transfer

• Uniformqualificationprocedures

• Standardized controls for all line elements

• Increased process reliability

• Greater packaging efficiency

• „One face to the customer“

Line concepts

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Integration and control

All the individual systems integrated into our packaging line need to work

perfectly with one another. That is why we have developed the Multivac

Line Control (MLC), a control element which monitors, analyzes and logs

the components of your packaging line. The MLC

• Coordinates all line elements

• Guarantees full traceability at a packaging level

• Allows you to store recipe data at a line level and simplifies product

changeover

• Can be connected to a manufacturing execution, enterprise resource

planning or operating data recording system if you wish to integrate

the line into your company‘s organizational and data structure.

Our support services

Validation

We are committed to delivering packaging solutions that enable you to meet your

own company standards and to comply with legal requirements as quickly, efficiently

and cost-effectively as possible. That is why our team of experts offers a wide

range of support services.

We have developed a qualification and validation package which complies with

GMP, GAMP5 and ISO guidelines. It includes:

- Validation plan

- Risk analysis

- Functional specification

- Installation and operation qualification

- Computer validation

We can also provide support for qualification and validation processes on site

and help you with special validations and retrospective validations for existing

packaging solutions.

Calibration

The relevant process parameters in our packaging lines can be calibrated to

ensure reproducible packaging quality and processes. We document these

results in a calibration protocol and provide you with appropriate documen-

tation for correcting any measurement errors.

FDA CFR 21 Part 11

In order to satisfy the requirements of the FDA CFR 21 Part 11 guidelines, our

IPC control system can include the following functions for monitoring and

documenting the packaging process:

• Personalized user administration

• Password administration

• Audit trail

• Recipe change history

• Data backup

Our support services

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Project management

From the original concept to the first test run – a skilled and experienced

project team will be at your side as we put your packaging solution into place.

We support you from the initial analysis through the implementation of your

packaging solution.

While training of your staff and final acceptance round off our portfolio of

services, our commitment to you does not end there. Our team is here for you

throughout the long service life of your Multivac system, and we’ll be ready

to help you meet the next challenge down the road.

Training

We offer comprehensive training courses to familiarize your employees with the

operation, care and maintenance of your machine, either at one of our training

centers around the world or on your own premises. Coaching is very much

a hands-on experience at the machine, but written materials are also provided at

the end of the course. This empowers your team to tap the full potential of your

new Multivac packaging solution.

Multivac worldwide

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Multivac – a global player

We employ more than 800 advisors and service technicians

in our 60-plus subsidiaries around the world. We have a presence

on all continents and in all major markets. We can offer expert

advice anywhere and at any time, provide a full range of services

in connection with all packaging issues, and support you in

finding the optimal and most efficient overall solution

for your needs. Our technical service

and a rapid spare parts delivery

system ensure maximum

availability of all installed

Multivac machines worldwide.

Put your trust in us.

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BETTER PACKAGING

www.multivac.com

10.595.9085, © Multivac, 11/09 · Printed in Germany on chlorfree paper. In keeping with improvements, designs and specifications subject to change without notice. Multivac is a registered trademark of Multivac Sepp Haggenmüller GmbH & Co. KG