safe and reliable packaging: koch medplus...validation-compliant packaging of the most sensitive...

KOCH expertise in packaging applications for the medical industry

Safe and reliable packaging: KOCH medplus

Expertise for the medical industry02

Safety and quality have a name: KOCH medplusValidation-compliant packaging of the most sensitive products

Everything needed to satisfy your stringent demands when packaging medical devices and pharmaceutical products – and more – that is KOCH medplus. This brand stands for our com-prehensive expertise and experience in this sensitive sector. It is a quality mark denoting added reliability, technology, equipment features, and support.

Whether transparent rigid blisters, soft blisters requiring less material, or completely recyclable cyclePac® mono-material packaging, and whether small, medium or large batches of single products or sets: KOCH packaging technology focuses on flexibility, achieved through modular design. Taking a basic module and additional components, we shape a cost-efficient, reliable packaging process that meets your specifications and complies with statutory requirements. For the semi-automated sealing of preformed blisters, for the fully automated forming, filling and sealing process, for the integrated processing of your product, from feeding to end-of- line packaging, and for inspection and marking in compliance with UDI or tracking and tracing requirements.

Sterile packaging of an artificial knee joint

in two blisters fitted into each other

Plaster box in blister

sealed with Tyvek®

Throat lozenges

in a blister wallet

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Medical devices and pharmaceutical products safely packaged

Sterile medical devices: filters, catheters, needles, intravenous drips, multipart infusion sets, inhalers, surgical instruments, suture material

Liquids: syringes, ampoules, vials, bottles, and pen injectors, single or in sets, sprays, paste-like products

Solids: tablets in wallets or individual weekly blister packs

Implants: artificial joints, stents

Dental products: single or multipart dental instruments, dental drills, dental implants

Diagnostic devices: dosimeters, matching and calibrating material, reagent test strips, quick tests, diagnosis sets

Expertise for the medical industry

04 Brand medplus

Optimum packaging of sensitive products

Safety, flexibility, and traceability are the three key factors when it comes to the planning of a blister machine or line for the packaging of devices for the medical industry. Full in-sight is needed: into the susceptible products, the exacting marketplace, and the special requirements.

In our business unit serving the medical industry, a team of specialists covering all aspects from development to machine qualification focuses solely on transforming your needs into the best respective packaging process. We offer our expertise from the out-set, provide advice at all stages, take over full implementation, and manage the project from start to finish. Packaging technology with added valueUnder the brand name KOCH medplus, we offer you a wide range of equipment features and associated services. Whether a standard machine, a special complex machine, or a highly flexible KOCH packagingLine medplus: GMP-compliant design and construction are as equally as important as cleanroom compatibility. Detailed documentation confirms the implementation of all specifications, thus verifying full functionality.

Special skills in machine construction and consultation

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Added value of the brand medplus

Individual project management by a team of multidisciplinary specialists

GMP machine design, machine construction according to GEP standards: no hollow areas, closed cable ducts, special lubricants, superior surface quality

Hygienic design: easy cleaning, use of medically appropriate materials

Cleanroom compatibility

Calibration of relevant process parameters for reproducible packaging quality

Qualification and validation documentation in accordance with GMP, GAMP5, ISO, and FDA

Marking and inspection, data acquisition and management in compliance with UDI or tracking and tracing requirements

Medical measuring

device in a blister with

lid material from roll

Left: Blister pack

containing syringes

Right: Multipart sterile

filter housing with tube

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KOCH packagingLine medplus06

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Forming

Fully integrated, safe, and highly flexible packaging As individual as your requirements: KOCH packagingLine medplus

Product handling (filling)

Sealing Punching

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End-of-line packaging

Your specifications and our machines form the basis on which we develop a highly auto-mated, flexible, and productive line. Fast, straightforward format changeovers ensure maximum machine uptime, while the concept allows the processing of small- as well as large-format products. It is also possible to incorporate various packaging formats in a universal pack – for optimized storage and logistics, as well as easier retail handling.

The basic version of every KOCH packagingLine medplus incorporates four perfectly synchro - n ized components: a blister machine, a product feeder, a blister grouping module, and end- of-line packaging. A robot handling system can be used to attain fully automated product feeding. As required, we also integrate systems for inline marking and inspection, and for high-quality, customized printing. Straight-forward, reliable operation is ensured by in-corporating all components, including those from other manufacturers, in a seamless, end-to-end IPC control system.

Guaranteed process quality – from a single sourceAt all stages – from the concept and packaging design to integration into ERP/MES systems and existing SCADA control systems – our expertise is at your disposal. As your premium partner, we are responsible for the entire project, offering a turnkey service from a single source. Included are documentation, in-house qualification, and globally available support services for long-term, smooth operation of your KOCH packagingLine medplus.

Grouping

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KDT KS-PL KDT KS-PL KDT KS-PL

KBS-PL KBS-KF shawpak KBS-PL KBS-KF shawpak

Rectangular blister smaller than the backing card

Sealing of the blister to the ready-made card

Forming, filling, and sealing of the blister

Placing of backing card, blister, and front card

Sealing of front and back card with blister

Folding to required wallet version

Forming, filling, and sealing of the blister

Cutting or punching of the blister

Semi-automated, just with sealing of the preformed blister

Semi-automated, just with sealing of the front and back cards

As reclosable wallet


Packaging process

S sealing

FFS forming filling sealing

Optional

Types of packaging

The right solution for every type of packagingFor a productive packaging process from the start

In addition to attractive presentation, packaging should protect the product. Particularly in the case of sterile products, it should be completely tight to ensure hygienic conditions until opened. Another increasing demand is for eco-friendly packaging. The inclusion of patient information, as well as the easy opening or reclosing of the packaging are likewise demands we address. We design the packaging accordingly, attune it to the technical capabilities of your machine, and develop a productive packaging process. Productive with regard to primary

Face seal blister Reasonably priced production form, e.g., for low-priced mass products

Trapped blister/wallet Optically superior pack, e.g., for tablets

Blister with lid material from roll Tight pack, e.g., for sterile products

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KDT KBS-KF

KBS-KF KB-KF plus KS-PL in line KBS-KF

Forming of two identical or differing blister halves for the front and back

Filling of one blister halfSealing of the two halvesCutting and/or punching of

the blister – only possible with KBS-KF

Forming and cutting/ punching of the open halves

Filling of the preformed halves

Closing of the clamshell


Types of packaging

and secondary packaging, and also in terms of the form and costs of production: simple and low-priced for mass products, more sophisticated for products of higher value. The key com-ponent is an individually configured KOCH blister machine in medplus design. This comprises a basic module for forming, filling and sealing (FFS), or just for sealing (S), plus additional com-ponents. The ideal solution also addresses the selection of suitable materials, the economical use of materials, and, if required, the separate recycling of the packaging materials.

Blister to blister (double blister) Transparent pack, e.g., for immediate recognition of product variations

Clamshell Versatile pack, e.g., containing more than one of the same product

Soft blister Flexible packaging requiring less material, permitting the ideal pack size for flexible products

Forming of two identical blister halves for the front and back

Filling of one blister halfSealing of the two halvesCutting of the blister

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cyclePac® Eco-friendly, e.g. suitable for sturdy, securely closed products

Forming of the cardboard cover out of prepared blanks cut smaller than the ready-made backing card

Product placement and sealing of the cardboard cover to the backing card

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Blister Machine KBS-KF medplus with chain conveyor

Sealing and Blister Machines10

Face seal blister Blister with lid material

from roll

Blister types

Exemplary version of Blister Machine KBS-KF medplus with lid material from roll

Ample format range, forming material diversity, and functional reliability

Whether rigid blister or soft blister; whether sealed, as a clamshell, or a blister with lid material from the roll to allow easy product removal and reclosing: Blister Machine KBS-KF medplus ensures high output for a wide variety of products. The large forming and sealing format as well as a maximum forming depth of 70 mm permit the processing of individual, bulky products or multipart sets.

The optimum sealing technology is selected to suit the lid material. The robust, smooth-running chain conveyor allows accurate product transfer from station to station, as well as maximum machine uptime. For one hundred percent quality control and traceability in accordance with UDI or tracking and tracing specifications, the machine can be fitted with appropriate inspection and printing systems – as is the case with all machines and lines in the medplus version.

Soft blisterBlister to blister

(double blister)

Sealing and Blister Machines 11

Modular configuration of Blister Machine KBS-KF medplus

Technical data

Forming area: from 150 x 300 mm t0 500 x 500 mm

Forming depth: 70 mm

Sealing format: from 150 x 300 mm to 500 x 500 mm

Output: 30 cycles/min., depending on packaging material/shape, and sealing duration

Chain transport with forming station

Multipart sterile filter

housing with tube and

cable set in blister

sealed with Tyvek®

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Forming material buffer

Heating station

Labeler

Lid material feeder

Marking (inkjet, laser)

Package output

Forming material feeder

Leaflet placer

Full or split cut punch

Automatic product feeder

Sealing station

FORMING

FILLING

SEALING

Forming station

Forming material transport via chain conveyor

Punching station

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Time-tested technology: with a high number of cycles for large batchesSealing Machine KS-PL and Blister Machine KBS-PL with linear pallet transport


Blister types

The Sealing Machine KS-PL and the Blister Machine KBS-PL package large batches of the same or similar products, and process all standard, rigid forming materials, as well as cyclePac® cardboard qualities reliably. Characteristic of both machines are the large format and sealing area – suitable, for example, for large-format, stand-up blisters or hanging blisters with a standard hanger hole – as well as the pallet section. This can be served manually or by a robot. The user-friendly, clear-cut design allows full control of the process at all times.

Both machines are suitable for a wide variety of medical devices in various packaging forms. They can both also be used for secondary packaging under cleanroom conditions.

Blister Machine KBS-PL based on proven technology – for the highly efficient

packaging of blisters made of PVC, PET, or other rigid materials

Face seal blister Trapped blister/wallet Blister with lid material from

roll (only with KS-PL)

cyclePac®

Extension pallet transport (variable)

Sealing station

Card placer

Card placer

Forming station


Forming material feeder

Labeler

Hanger hole punch

Split cut punch Hanger hole punch

Marking (inkjet, laser) Package output

Forming material buffer

FORMING

FILLING

SEALING

Pallet transport

(linear)

KBS-PL

KS-PL


Technical data

Forming area: 250 x 500 mm

Forming depth: 67 mm

Sealing format: 238 x 580 mm

Output: 20 cycles/min., depending on forming material, packaging shape/ size, and sealing duration

Modular configuration of Blister Machine KBS-PL or Sealing Machine KS-PL

Bronchial drops in a face seal blister

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Blister types KDT medplus

Face seal blister Blister to blister

(double blister)

Turntable Machine KDT medplus and Forming and Sealing Machine shawpak KOCH SP

Flexibility in a compact format

Turntable Machine KDT medplus The cost-effective packaging of small to medium-sized batches is where the KDT comes into its own with its low purchase price, reasonably priced format parts, economical energy con-sumption, and well-devised machine concept with state-of-the-art technology. The basic machine version incorporates a turntable with four sealing tools and a unit for thermal sealing.

Extension optionsAn additional card placer system allows the automated feeding of different packaging elements such as blisters, lid material from the roll, or as blanks or front cards for trapped blisters. The KDT medplus can be automated with a product feeder and other components.

Forming and sealing machine shawpak KOCH SPThe productive heart of the machine is the servo-driven forming drum. As it transports the webs through the process without any gripper chains, it is very efficient and low in main-tenance. The product is simply loaded into the top of the form-ing drum, either manually or using a robot handling system. The single-lane mode of operation ensures a smooth process and precision monitoring. Guided operation is straightforward using the color touchscreen. The shawpak KOCH SP is available with various format areas and blister depths of 80 or 100 mm.

Turntable Machine KDT – here the

basic version in GMP-compliant

medplus design

The shawpak KOCH SP with

an output of 25 blisters per

minute

Trapped blister/wallet Blister with lid material

from roll

cyclePac®

Blister with lid material

from roll

Blister types shawpak KOCH SP


Face seal blister

Technical data KDT medplus

Blister depth: up to 70 mm

Sealing format: 250 x 360 mm

Sealing force: 30 kN

Output: 12 cycles/min., depending on packaging material/shape, and sealing duration

Modular configuration of the Turntable Machine KDT medplus

Technical data shawpak KOCH SP

Forming area: from 220 x 200 mm to 620 x 250 mm

Blister depth: max. 100 mm

Output: up to 25 blisters/min.

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Film blank and backing card placer

Front card placer

Horizontal blister magazine

Lid material feeder with punch/without punch

Package output


Turntable machine with sealing station

Package output with marking

and inspection

Backing card placer

For a transparent supply chain, reliable from start to finishMarking and inspection in compliance with UDI requirements

Standardized, unique marking to ensure seamless traceability and protect against falsification is defined by the unique device identification (UDI) legislation governing medical devices. A UDI system comprises three elements: device and production identifiers (UDI data), the data carriers, i.e. the product and packaging (UDI device), and the global UDI database.

Our experts help you to apply these specifications to your packaging process. Included here is the integration of marking and inspection systems, as well as interface management for data transfer to higher-ranking systems – including tracking and tracing, of course. The benefits of a UDI system using automated data acquisition are a further aspect to be considered.

Class I Class IIa Class IIb Class III

> > > >

Medical instruments Dressing material

Dental inlays Contact lenses Disposable syringes

Respirators Dialysis devices Condoms Cleaning solutions

for contact lenses Dental implants

Cardiovascular and neurological catheters

Coronary stents, cardiac valves, cardiac pacemakers

Absorbable suture material

Breast implants

Surgical instrument Disposable syringe Inhalation system Artificial knee joint

Examples of medplus packaging expertise in all risk classes

UDI-compliant marking and inspection 16

UDI-compliant marking and inspection 17

Thermal inkjet printing system with four print heads

for the marking of blister cards

Inline: marking in perfect qualityAll packaging units, from the smallest to the largest, have to be marked in compliance with UDI or tracking and tracing specifications. We select the appropriate printing systems and integrate them into your blister machine or KOCH packaging line. All relevant data such as the manufacturer’s identification, product reference code, batch number, serial number, and production date are applied inline in the correct com-bination and quality.

High-end monitoring in real time: inspection modulesOne hundred percent quality control during the ongoing process with accurate precision at high speeds: We integrate suitable systems at the relevant positions for contact-free, optical inspection. For example, to check product presence or position, monitor robot feeding, verify product data and print images during marking, or make a final inspection at the machine output. Data is transmitted to the machine control system, or to the next station, for reliability and transparency throughout the entire process.

Exemplary marking and inspection system that prints and subsequently verifies

variable product data

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Qualification and automation18

Documented: top process and packaging qualityQualification from the machine design to acceptance

A safely manufactured medical device demands perfect results from all processes, including the packaging itself. Full functionality must be documented. We execute the operational, hardware, and software design according to your specifications. Our experts ensure detailed documentation covering design qualification, the risk analysis of relevant process steps, the factory acceptance test, the SAT, and subsequent installation and operational qualification. We supply all required documents for machines and follow-up orders according to your wishes and in compliance with EU or FDA (GMP/GAMP5) specifications.

KOCH qualification service from start to finish

Design qualification

Qualification planning

Functional design specification (FDS)

Technical specification (TS)

GMP risk analysis report

Installation qualification (IQ) including cross- checking of the machine at KOCH

Operational qualification (OQ) including cross- checking of the machine at KOCH

Traceability matrix

Machine qualification as

required by the customer

We offer various feeding and handling systems for a smooth material flow and accurate positioning of even the smallest product in fully automated packaging processes. Loose as well as pre-packaged products can be transported, unpacked, and placed as required.

Use can be made of a Delta Robot KRH-D, for example. This precision handling system operates reliably at high speed. Sorted products are picked up and placed in the preformed blisters. The robot can operate individually or be linked inline to other KRH-D units. An alternative for high-precision feeding and positioning is a 6-axis robot. Its 1,000 mm radius allows flexible application for a wide range of packaging jobs and formats.

Highly productive and variableKOCH robot handling

Automation and digitalization 20

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Faster, better, easier, and more convenientDigitalization in special machine manufacturing with K 4.0

Our K 4.0 portfolio offers you tailored, practice-oriented services for digitalization in special machine manufac-turing. Solutions perfectly matched to your KOCH machine make your everyday packaging easier and more efficient. Wherever your location.

Smart support worldwide: service glassesService glasses permit direct, immediate support at the machine when an on-site visit is not imperative. An expert is connected to your operator and guides him through preventive maintenance or troubleshooting measures. For reduced service costs and increased machine uptime.

Online ordering of spare parts: the SpareParts ManagerYou only need to make a few clicks to order spare, wearing, and format parts for your machine configuration. Naviga-tion is straightforward; the parts are quickly identified using drawings and 2D models. Additional information and files can be integrated for each machine.

Intuitively correct operation: the HMI panelThe optics of a tablet, 21" monitor, graphical switch panel, as well as key machine views and parameters at a glance: the panel permits intuitively correct operation and fast setups – directly at the machine or via mobile devices.

Faster commissioning – using a virtual modelYour machine is ready for operation sooner using virtual commissioning based on 3D machine simulation and original software. Personnel can be trained in advance.

Access machine parameters: K 4.0 smart appThe K 4.0 smart app gives you access to your machine parameters at all times: using a QR code for individual production data; using beacon scanning for live produc-tion data.

KOCH is … innovative, flexible, and competentOur commitment to being a trendsetter and technology leader in special machine manufacturing is lived up to by over 400 employees each and every day. Using advanced development expertise with a focus on complex requirements, we operate as a partner on an equal footing – particularly when it comes to singular projects. Packaging applications for national and international customers in the fields consumer products, medical industry, contact lenses, and services.

A key element at KOCH is personal support provided by a team of specialists. At our headquarters in Pfalzgrafenweiler, in the offices in France, China, Singapore, India, and the USA, as well as through our global sales and service partners. Furthermore, as a member of the Uhlmann Group, we have excellent connections to the specialists in pharmaceutical packaging.

Member of the Uhlmann Group

KOCH Pac-Systeme GmbHDieselstrasse 1372285 Pfalzgrafenweiler GermanyPhone +49 7445 181-0Fax +49 7445 [email protected]

www.koch-pac-systeme.com

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safe and reliable packaging: koch medplus...validation-compliant packaging of the most sensitive...

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