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Packaging of medical and
pharmaceutical products
Packaging of medical and
pharmaceutical products
2	 BETTER
PACKAGING
BETTER
PACKAGING
Content
3
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
4	
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.
5
6		
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
7
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.
8
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.
9
BETTER
PACKAGING
BETTER
PACKAGING
10	
	
	
	
	
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.
11
12	
	
	
	
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.
Thermoformers
Multivac 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:
Our portfolio
13
	
	
	
	
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
14	
	
	
	
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
15
	
	
	
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.
16	
	
	
	
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:
•	 High speed and precision
•	 Quick and easy retooling
•	 Consistent clean design
•	 Compact, space-saving construction
Multivac handling modules can be used for a wide variety of
products and packaging types:
•	 Loading
•	 Unloading
•	 Buffering
•	 Orientation
•	 Ejection and bypass functions
•	 Late-stage customization
•	 In-process control
Our portfolio
17
18	
	
	
	
	
Our portfolio
19
	
	
	
	
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
•	 Quality and completeness of the pack contents
•	 Positioning and printing of the label
•	 Presence and legibility of variable product data (OCV, OCR),
	 including barcodes, data matrix codes, batch numbers, etc.
•	 Packaging quality in terms of shape, color and surface finish
•	 Individual pack specifications
20	
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.
	 21
22	
	
	
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
•	 Uniform qualification procedures
•	 Standardized controls for all line elements
•	 Increased process reliability
•	 Greater packaging efficiency
•	 „One face to the customer“
Line concepts
23
	
	
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
24
25
	
	
	
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
26	
	
	
	
	
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.
27
BETTER
PACKAGING
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

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Multivac Medical

  • 1. Packaging of medical and pharmaceutical products Packaging of medical and pharmaceutical products
  • 3. 3 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
  • 5. 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. 5
  • 6. 6 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
  • 7. 7 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.
  • 8. 8 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.
  • 9. 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. 9
  • 11. 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. 11
  • 12. 12 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. Thermoformers Multivac 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: Our portfolio
  • 13. 13 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
  • 14. 14 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
  • 15. 15 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.
  • 16. 16 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: • High speed and precision • Quick and easy retooling • Consistent clean design • Compact, space-saving construction Multivac handling modules can be used for a wide variety of products and packaging types: • Loading • Unloading • Buffering • Orientation • Ejection and bypass functions • Late-stage customization • In-process control Our portfolio
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  • 19. 19 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 • Quality and completeness of the pack contents • Positioning and printing of the label • Presence and legibility of variable product data (OCV, OCR), including barcodes, data matrix codes, batch numbers, etc. • Packaging quality in terms of shape, color and surface finish • Individual pack specifications
  • 21. 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. 21
  • 22. 22 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 • Uniform qualification procedures • Standardized controls for all line elements • Increased process reliability • Greater packaging efficiency • „One face to the customer“ Line concepts
  • 23. 23 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.
  • 24. 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 24
  • 25. 25 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.
  • 26. Multivac worldwide 26 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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  • 28. BETTER PACKAGING 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