innovators of specialised equipment for … · innovators of specialised equipment for package leak...

INNOVATORS OF SPECIALISED EQUIPMENT FOR PACKAGE LEAK DETECTION, PRODUCT RECOVERY AND BLISTER PACKAGING IN THE PHARMACEUTICAL AND HEALTHCARE MARKETS SINCE 1980.

INNOVATORS OF SPECIALISED EQUIPMENT FOR

PACKAGE LEAK DETECTION, PRODUCT RECOVERY

AND BLISTER PACKAGING IN THE PHARMACEUTICAL

AND HEALTHCARE MARKETS SINCE 1980.

CONTENTS

About Us 04

1. PACKAGING SOLUTIONS 07

EZ Blister 10

EZ MedPak 12

2. PRODUCT INTEGRITY 15

VisionScan 18

PakScan 20

MediScan 22

BottleScan 24

3. PRODUCT RECOVERY 27

Press Out - Manual, Manual Wide, 30

Semi-Automatic, Automatic

Press Out Universal 32

Press Out Universal Mini 34

Which Press Out? Quick Reference Table 36

Customer Service 37

TASI Group 38

Bonfiglioli Engineering 39

SMARTER INTEGRITY

SMARTER PACKAGING

SMARTER RECOVERY

03

Established in 1980, Sepha is an award winning specialist engineering business based in Belfast, Northern Ireland. Our focus is on the global pharmaceutical and medical packaging market, and our main areas of expertise involve supplying innovative packaging solutions, inspection and recovery products to clients who manufacture blister packs.

At our Belfast HQ we have a young, highly educated and skilled workforce, who design, develop and manufacture all our products in-house, and we export to over 35 countries globally.

Sepha is a well-established brand in the global pharmaceutical market, known for its continuous innovation and customer-focused solutions. We have developed a strong global sales, customer service and support network in all major pharmaceutical manufacturing markets. As a result, we can include the world’s top 10 pharmaceutical companies as clients.

Our products incorporate unique, innovative and patented technologies to help meet the requirements of our demanding client base. In particular, our products are chosen for their ability to improve quality assurance procedures and to reduce manufacturing costs, enabling clients to efficiently meet the stringent regulatory requirements of the industry. Our product range incorporates 3 main divisions

• Packaging Solutions• Product Integrity Testing• Product Recovery

In 2013, Sepha joined the TASI Group of companies and in so doing, has become part of the single largest pharmaceutical test and inspection group worldwide.

ABOUT US

04

PACKAGINGSOLUTIONS

PRODUCTINTEGRITY

PRODUCTRECOVERY

BLISTER PACKING MACHINES AND SERVICES THAT OFFER FLEXIBILITY AND HIGH QUALITY BLISTER PACKS FROM A WIDE VARIETY OF PACKAGING MATERIALS.

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1. PACKAGING SOLUTIONS

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1. PACKAGINGSOLUTIONS

SMALL SCALE, HIGH QUALITY BLISTER PACKAGING MACHINES AND SERVICES THAT ARE IDEAL FOR R&D, PRODUCT DEVELOPMENT AND CLINICAL TRIALS.

Ideal for small batches of pharmaceutical, medical or nutraceutical products from tablets and capsules to ampoules and medical devices, the EZ range is economical, time efficient and suitable for:

• clinical trials and stability studies• package development• marketing samples• low volume production eg. of specialist drugs

The compact and easy to use model provide a 3-in-1 operational flexibility and combines the convenience of a lab-scale machine with the capability of a full sized production machine.

CONTROL YOUR SCHEDULE

Why wait until your Production Department can fit your small R&D batches into their busy schedule? EZ Blister and EZ MedPak give your lab total control, so clinical trials, package development and stability studies are completed on time and to budget. Every day saved in R&D

is a day when a new product can make extra profits on the marketplace. Your blister packing department also benefits as they will not have to clean and set-up large scale packaging equipment for small batches.

FLEXIBILITY

With the capability to handle all thermoform and cold-form materials the EZ range offers high quality packs for all requirements including child-resistant/peelable blister packs, sachets, and monitored unit dose packs.

REPEATABLE RESULTS

Programme bespoke settings for temperature and air pressure through the electronically monitored controls or use the pre-set limits for easy operation.

For more information about R&D blister packing visit www.sepha.com

“THESE SOLUTIONS HAVE BEEN DEVELOPED IN RESPONSE TO GLOBAL DEMAND FROM MAJOR PHARMACEUTICAL, MEDICAL DEVICE AND CLINICAL TRIAL LABORATORIES FOR BLISTER PACKING SOLUTIONS THAT ARE FLEXIBLE, ADAPTABLE AND CAPABLE OF HANDLING COMPLEX PACK DESIGNS AT MINIMAL COST.”

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EZBLISTER

A COMPACT, CUSTOMIZABLE BLISTER PACKAGING MACHINE FOR CLINICAL TRIAL LABORATORIES AND FACILITIES REQUIRING LOW VOLUME PACKAGING SOLUTIONS.

EZ BLISTER

FEATURES & BENEFITS

• Customizable to individual commercial and manufacturing requirements

• Easy setup via HMI and minimal training required

• Compact space saving bench top design

• Precision engineered knurled or heat sealing plates

• Forms from pre-cut pieces of forming material

• Modified Atmosphere Packaging (MAP) function available as an optional extra.

• Cold forming capability

• Tool-less changeover of format parts in less than 2 minutes

• All machine parts either grade 304 stainless steel, anodized aluminium or PTFE

• Perforated cutting tools (optional)

• Teflon coated forming plates

• Operating speed of approx. 200 cycles per hour for any single operation*

*Tooling and material dependant

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EZ Blister has a range of options that can be selected to tailor and format the machine to meet individual commercial, manufacturing and technological requirements. The MAP option enables a full range of blisters to be created for stability studies.

Blister packing of tablets, capsules, ampoules, sachets, pouches and other products can be achieved from either thermoforming (eg. alu/pvc) or cold forming (alu/alu). Teflon coatings help optimize production when using difficult materials, and full pack traceability can be assured with the addition of a coding system.

OPTIONS

• Modified Atmosphere Packaging (MAP) capability

• Stainless steel casing grade 304

• Coding facility

• Mobile workstation with optional reel holder

• Tooling design service

• Pack design service

MODIFIED ATMOSPHERE PACKAGING (Optional) MAP option allows packs to be flushed with a gas as specified by the client. Flushing can be configured for set times and pressure levels.

MACHINE OPERATIONThe EZ Blister offers a 3-in-1 manufacturing process via the HMI controls.

FORMINGPre-cut pieces of forming material are placed in the machine to create trays that are formed to exact product requirements.

SEALINGThe formed trays are sealed with pre-cut pieces of the selected lidding material using knurled or heat sealing plates. Product traceability can be achieved by choosing the option of code embossing the lidding material.

PERFORATING AND CUTTING The sealed trays are cut and perforated using a precision die cutter.

TECHNICAL SPECIFICATION

PACK TYPE Blister

PACK DIMENSIONS Max. format area: 180mm x 120mm

Max. form depth (TF/CF): 9mm

Max. material width: 165mm

Min. material width: 135mm

*Material dependant - deeper pockets may be considered upon request

OPERATION Semi-automatic

CONSTRUCTION Stainless Steel (Grade 304)

USER INTERFACES Touchscreen HMI, hand operated regulators, push buttons

CONTROLS Temperature: 0 - 200°C settable ±1 °C

Pressure: 0.2 – 0.6 MPa (Force: 6.3 – 18.8 kN)

Timers: 0 – 99.9 sec settable ±0.1 sec

Counter: 0 - 999 cycles

UTILITIES Electrical: Min 110V Single phase, 15A

Min 230V Single phase, 6.5A

Air Supply: Min. 250 L/min at 0.6 MPa

OPERATING SPEED Approx. 200 cycles per hour for any single operation

TOOLING CHANGEOVER 2-3 minutes

TOOLING WARM-UP Approx. 10-15 minutes

MACHINE DIMENSIONS 655(W) x 715(D) x 555(H) mm

WEIGHT Machine: 138 kg

Tooling: 12 kg

Shipping: 200 kg (inc. tooling)

WARRANTY Supplied with a 12 month warranty. (Service Level Agreements and / or extended

warranties are available for additional support).11

EZ BLISTER SHARES THE TECHNOLOGY AND PROCESSES

OF LARGER PRODUCTION MACHINES TO CREATE HIGH

QUALITY PACKAGING.

EZMEDPAK

A COMPACT, LAB SCALE PACKAGE DEVELOPMENT MACHINE THAT HAS BEEN DESIGNED SPECIFICALLY FOR THE MEDICAL DEVICE MARKET WHERE STERILITY MAINTENANCE AND BARRIER PROTECTION AGAINST MICROBIAL PENETRATION IS REQUIRED.

EZ MEDPAK

FEATURES & BENEFITS

• Low volume packaging development unit designed to create bespoke packs for a wide range of medical & surgical devices

• Can be customised to meet individual customer needs and specifications

• Capable of handling a range of forming materials including PVC, PCTFE Laminates, PETG*

• Lidding options include aluminium, peelable and paper-backed foils and Tyvek

• Modified Atmosphere Packaging (MAP) function available as an optional extra

• Ability to create multiple barrier solutions

• Peel or push-thru product access options

• Full package design and development service available

• Operating speed of approx. 200 cycles per hour for any single operation*

• Auto safety cut-off via light curtain

*Tooling and material dependent

EZ MedPak enables R&D labs to design, create and manufacture product specific packaging in a lab environment, without the need to outsource package production. The unit is capable of handling most medical device packaging and lidding materials such as PETG, aluminium, PVC, peelable, paper-backed and Tyvek.

Our package design experts can design bespoke product tooling that enables clients to showcase their products to the maximum potential.

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OPTIONS (see EZ Blister options)

APPLICATIONSApplications include:

• Pre-filled syringes

• Diagnostic devices

• Surgical stents

• Inhalation devices

• Dental implants

• Medical tray kits

MODIFIED ATMOSPHERE PACKAGING (Optional) MAP option allows packs to be flushed with a gas as specified by the client. Flushing can be configured for set times and pressure levels.

MACHINE OPERATION

The EZ MedPak offers a 3-in-1 manufacturing process based on:

FORMINGPre-cut pieces of forming material are placed in the machine to create trays that are formed to exact product requirements to a depth of 25mm.

SEALINGThe formed trays are sealed with pre-cut pieces of the selected lidding material using knurled or heat sealing plates. Product traceability can be achieved by choosing the option of code embossing the lidding material.

PERFORATING AND CUTTING The sealed trays are cut and perforated using a precision die cutter.


PACK TYPE Blister and Tray

PACK DIMENSIONS Max. format area: 220mm x 120mm

Max. form depth (TF/CF): 25mm

Max. material width: 165mm

Min. material width: 135mm

*Material dependant - deeper pockets may be considered upon request



USER INTERFACES Touchscreen HMI, Hand operated regulators, Push buttons

CONTROLS Temperature: 0 - 200°C settable ±1 °C

Pressure: 0.2 – 0.6 MPa (Force: 6.3 – 18.8 kN)

Timers: 0 – 99.9 sec settable ±0.1 sec

Counter: 0 - 999 cycles

UTILITIES Electrical: Min 110V Single phase, 15A

Min 230V Single phase, 6.5A

Air Supply: Min. 250 L/min at 0.6 MPa

OPERATING SPEED Approx. 200 cycles per hour for any single operation

TOOLING CHANGEOVER 2-3 minutes

TOOLING WARM-UP Approx. 10-15 minutes

MACHINE DIMENSIONS 670(W) X 715(D) X 555(H) mm

WEIGHT Machine: 145 kg

Tooling: 20 kg

Shipping: 215 kg (inc. tooling)

WARRANTY Supplied with a 12 month warranty. (Service Level Agreements and/or extended

warranties are available for additional support). 13

EZ MEDPAK GIVES MEDICAL DEVICE MANUFACTURERS

THE FLEXIBILITY AND CONTROL TO DEVELOP & PRODUCE

COMPLEX, HIGH QUALITY PACKAGING FROM A RANGE

OF MATERIALS.

TECHNOLOGICALLY ADVANCED, NON-DESTRUCTIVE PACKAGE LEAK TESTING MACHINES THAT DELIVER ACCURACY, EFFICIENCY AND PRODUCT INTEGRITY ACROSS PHARMA, FOOD AND OTHER MARKETS.

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2. PRODUCT INTEGRITY

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2. PRODUCTINTEGRITY

INNOVATIVE, NON-DESTRUCTIVE PACKAGE LEAK DETECTION EQUIPMENT THAT ENABLES OUR CUSTOMERS TO IMPROVE THE ACCURACY OF THEIR LEAK DETECTION PROCEDURES AND REDUCE COSTS.

Our technology based, non-destructive leak detection range is capable of detecting leaks in a wide range of pharmaceutical blister packs, induction-sealed bottles, sachets, pouches and medical device packaging. Our test process is clean and dry, allowing product that has been tested to be recovered and returned to the production line.

WHY TEST PACKS FOR LEAKS?

Testing is vital to ensure drug stability through protection from moisture, air and bacteria. Leak testing also minimises reject blisters and reduces deblistering and excess waste disposal. Performing leak testing before stability studies will confirm that all results apply to blisters which are known to be properly sealed.

FULLY VALIDATED RESULTS

With a reliable validation process as standard, operator subjective judgments and errors are avoided.

21 CFR Part 11

All of our machines have data capture and export capabilities, and can form part of a 21 CFR Part 11 compliant system.

ACCURATE AND CLEAR READINGS

Academic studies and whitepapers have proven that Sepha technology is significantly more accurate and reliable at detecting leaks in blisterpacks than other destructive methods of leak detection. Our detection technology can test for leaks as small as 10 micron and will identify the precise pocket or area of the pack that is leaking. These results can then be stored and exported for quality control and audit records.

For more information on non-destructive leak testing visit www.sepha.com

“OUR GOAL IS TO DEVELOP SMARTER, MORE ACCURATE, NON-DESTRUCTIVE LEAK DETECTION EQUIPMENT THAT IS SIMPLE TO USE, SAVES OUR CUSTOMERS TIME AND MONEY, IMPROVES THEIR ENVIRONMENTAL FOOTPRINT AND GUARANTEES RELIABLE AND REPEATABLE RESULTS.”

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VISIONSCAN

VISIONSCAN IS A TOOL-LESS, NON-DESTRUCTIVE LEAKDETECTION DEVICE FOR PHARMACEUTICAL BLISTER PACKS.

VISIONSCAN

FEATURES AND BENEFITS

• Non-destructive seal and leak detection device designed for blister packs

• Incorporates imaging technology that will detect defects in individual blister pockets, channel leaks and weak seals down to 15 micron

• Tool-less. Ideal for production lines running multiple products

• Can test multiple packs per test cycle

• Rapid test time down to 30 seconds per test*

• Operating system can store up to 30,000 product types

• Simple operator use via a touch screen interface

• Can test packs that contain tablets/capsules in multiple material/design formats

• Objective, repeatable pack test for each product

• Capable of storing and exporting data for audit and quality control purposes

• Can form part of 21CFR part 11 compliant system

• Improved environmental impact

• Flexible, mobile table top device

VisionScan is simple to operate and requires no tooling, making it ideal for high volume pharmaceutical manufacturers and packagers where high levels of quality control, cost reduction and multiple product changes are required.

It uses camera and projection technologies, combined with differential pressure to detect weak seals or leaks in blister packs. VisionScan generates accurate, reliable and repeatable results with clear pass or fail information.

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*pack dependent

MACHINE OPERATION

Test methods are developed for each pack format and are stored as ‘recipes’ for that pack type.

1. LOAD PACKS AND SELECT PRODUCT (IMAGE 1)

Load packs, close drawer and select relevant product test method from the product recipe library. Assign batch details.

2. START TEST AND IDENTIFY PACKS (IMAGE 2)

Press ‘Start Test’. The camera locates the packs and an image is displayed so that the operator can confirm that the correct number has been identified.

3. REFERENCE IMAGE AND VACUUM PHASE IMAGE (IMAGE 3)

VisionScan then takes an image of the packs, pulls a vacuum, takes a second image and compares the

two. If required, small holes can then be detected by waiting for a set dwell time, releasing some of the vacuum and capturing another image. All of the images are then compared and analysed for pocket movement using product specific parameters.

4. PASS OR FAIL SCREEN - PASS (IMAGE 4), FAIL (IMAGE 5)

The results screen shows a pass or fail result for each individual pocket. If movement is identified, a simple ‘green’ for pass will be displayed on the pocket, indicating that there are no defects present. If no movement is identified, the pocket is defective and a ‘red’ fail result will be shown on that defective pocket. VisionScan is capable of detecting defects down to 15 micron.

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USING THE LATEST CAMERA IMAGING TECHNOLOGY, IT OFFERS MODERN PHARMACEUTICAL MANUFACTURERS A FLEXIBLE, RELIABLE, OBJECTIVE AND COST SAVING ALTERNATIVE TO DESTRUCTIVE BLISTER PACK TEST METHODS SUCH AS BLUE DYE.


PACK TYPE Blister pack

TEST AREA 220mm x 160mm (8.7 x 6.3”)



USER INTERFACE 15” XGA TFT display, 1024 x 768 pixels with resistive touch screen

UTILITIES Electrical: 110/230V single phase

Air: 6 Bar

CONFIGURATION 2 x USB ports 1 x Ethernet port

TEST CYCLE From 30 seconds

TOOLING CHANGEOVER N/A

AUDIT COMPLIANCE Can be run in compliance with 21CFR Part 11


(24 x 23.6 x 31.9”)

MACHINE WEIGHT 80kg (176lbs) / Shipping Weight: 160kg (353lbs)

WARRANTY Supplied with a 12 month warranty. (Service Level Agreements and/or extended warranties are available for additional support.

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PAKSCAN

NON-DESTRUCTIVE MULTI-PRODUCT LEAK TESTING FOR POUCHES, SACHETS, SMALL MEDICAL DEVICES AND OTHER FLEXIBLE PACKS (NON-POROUS MATERIALS) WHICH CONTAIN DRY POWDER OR A SOLID COMPONENT.

PAKSCAN

FEATURES & BENEFITS

• Non-destructive seal integrity and leak detection device that uses force decay technology to detect weak seals and holes down to 10 micron

• Can test up to 4 packs simultaneously as standard. (5 & 6 pack options also available)

• Capable of handling dry, non-porous packages up to 275mm x 90mm x 50mm.

• Easy operator use via touch screen interface and easy load chamber

• Capable of storing multiple test methods for up to 10,000 product types • User defined password protection ensuring multiple operator use • Easily validated system • Repeatable test with objective pass/fail results • Test results can be printed, exported via USB (x2) or integrated into local quality control system via Ethernet cable • Audit data available and fully 21CFR part 11 compliant

Using force decay technology, PakScan offers a clean and dry leak detection solution for modern manufacturers and packaging companies that pack dry product in pouches, sachets and other non-porous flexible packaging. The system can detect leaks as small as 10μm in up to four packs simultaneously and provides an objective pass/fail result. Data can be stored and exported for audit purposes.

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A TOUCH SCREEN USER INTERFACE MONITORS THE PAKSCAN PROGRESS THROUGH A VIRTUAL INSTRUMENT PANEL.

1. EVACUATION PHASE

A pre-determined level of vacuum is applied to generate an expansive force which is monitored throughout the test cycle.

2. STABILISATION PHASE

Following evacuation of the vacuum, a stabilisation phase allows the conditions to normalise.

3. DECAY TEST PHASE

The decay test phase measures any reduction in head space pressure. If the expansive force decays by more than a set amount the pack will be classed as a failure.

4. GROSS HOLE IDENTIFICATION PHASE

At the end of the decay phase, if the reactive force is less than the pre-determined level in the test method, a pack will be classed as a gross leak failure.

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MACHINE OPERATION

Sample packs are loaded into a custom designed product nest and the test chamber lid is closed. There are then 4 key test phases:


PACK TYPE Sachets, pouches, bags, MAPs (in flexible, non-porous materials)

TEST AREA 275x 90 x 50mm (10.8 x 3.5 x 2.0”) Per pack



USER INTERFACE 12.1" 800 x 600 TFT LCD display with Resistive Touch Screen


Air: 6 Bar



TOOLING CHANGEOVER Approx. 3 minutes



(30 x 37.4 x 68.5”)

MACHINE WEIGHT 200kg (441lbs) / Shipping weight: 300kg (661lbs)

WARRANTY Supplied with a 12 month warranty. (Service Level Agreements and/or extended

warranties are available for additional support).

MEDISCAN

MEDISCAN IS A TOOL-LESS, NON-DESTRUCTIVE LEAK DETECTION DEVICE FOR LARGER SINGLE NON-POROUS POUCHES, SACHETS AND MEDICAL DEVICE PACKAGING.

MEDISCAN

FEATURES & BENEFITS

• Non-destructive seal integrity and leak detection device

• No tooling required, making it highly flexible across a number of pack types and sizes

• Capable of detecting weak seals and holes down to 10 micron*

• Table top device

• Capable of handling wet** or dry non-porous packages up to 100mm x 200mm x 250mm

• Easy operator use via touch screen interface and easy load chamber

• Capable of storing multiple test methods for up to 10,000 product types

• User defined password protection ensuring multiple operator use

• Easily validated system

• Production of objective and repeatable results

• Test results can be printed, exported via USB (x2) or integrated into local quality control system via Ethernet cable

• Fast, efficient test speed

• Audit data available and fully 21CFR part 11 compliant

Mediscan incorporates the leak detection technology and software, developed by Sepha, that is utilized on a daily basis by top global pharma companies to ensure product integrity in their pharmaceutical production lines.

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*pack dependent**product dependent

A NON-DESTRUCTIVE LEAK TEST MACHINE GIVING ACCURATE, OBJECTIVE MEASUREMENTS TO ENSURE OPTIMAL PRODUCT INTEGRITY.

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1. EVACUATION PHASE

A pre-determined level of vacuum is applied to generate an expansive force which is monitored throughout the test cycle.

2. STABILISATION PHASE

Following evacuation of the vacuum, a stabilisation phase allows the conditionsto normalise.

3. DECAY TEST PHASE

The decay test phase measures any reduction in head space pressure. If the expansive force decays by more than a set amount the pack will be classed as a failure.

4. GROSS HOLE IDENTIFICATION PHASE

At the end of the decay phase, if the reactive force is less than the pre-determined level in the test method, a pack will be classed as a gross leak failure.

MACHINE OPERATION

Sample packs are loaded into a custom designed product nest and the test chamber lid is closed. There are then 4 key test phases:


PACK TYPE Sachets, pouches, bags, MAPs (in flexible, non-porous materials)

TEST AREA 200(W) x 250 (L) x 100(D)mm (7.9 x 9.8 x 3.9”)



USER INTERFACE 8.4" SVGA (800 x 600) color TFT LCD display


Air: 6 Bar



TOOLING CHANGEOVER N/A



(27.6 x 21.6 x20”)

MACHINE WEIGHT 63kg (138lbs) / Shipping weight:113kg (249lbs)

WARRANTY Supplied with a 12 month warranty. (Service Level Agreements and/or extended warranties are available for additional support).

BOTTLESCAN

A TOOL-LESS, NON-DESTRUCTIVE MULTI-BOTTLE INTEGRITY TESTER FOR INDUCTION-SEALED PHARMACEUTICAL BOTTLES.

BOTTLESCAN

FEATURES & BENEFITS

• Non-destructive inspection device that detects defects in bottles and induction seals down to 15ɥm*

• Tests up to 4 bottles per test cycle in a test time of 30-90 seconds

• Operating system can store up to 30,000 product types

• No tooling required so ideal for production lines with multiple products

• Quick, repeatable test with objective pass/fail results

• Audit data available and can form part of 21 CFR Part 11 compliant system

• Can handle multiple bottle sizes

• Configurable methods allow user to decide machine sensitivity

• Simple operator use with minimal training required

BottleScan is a non-destructive integrity tester for induction-sealed pharmaceutical bottles that contain solids or powders. It has a unique ability to test up to 4 bottles per test cycle, a tool-less design and incorporates force decay technology to offer a technologically superior QA/QC check as part of cGMP.

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*dependent on bottle type

RAPID AND OBJECTIVE INTEGRITY TEST FOR INDUCTION SEALED BOTTLES. STORES AND EXPORTS DATA TO OPTIMISE QUALITY CONTROL SYSTEMS.

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OPERATION Semi Automatic

TEST CYCLE TIME 30-90 seconds

SENSITIVITY Down to 15 microns

BOTTLE DIMENSIONS 30mm(W) x 60mm (H) to 100mm(W) x 150mm(H) (without cap)

CONFIGURATION DVD/CD-ROM drive Ethernet 2 x USB

POWER SUPPLIES Electrical: 110/230V AC Single Phase

Air: 6 Bar

USER INTERFACES 17” 1280 x 1024 SXGA TFT display with resistive touch screen

AUDIT COMPLIANCE Machine can be used as part of a 21-CFR Part 11 system


MACHINE DIMENSIONS 750 (W) x 600 (D) x 810 (H) mm (30” x 24” x 32”)

MACHINE WEIGHT 125kg (275lb) / Shipping Weight: 260Kg (573lb)

WARRANTY Supplied with a 12 month warranty. ((Service Level Agreements and/or extended warranties are available for additional support).

1. LOAD BOTTLES AND SELECT PRODUCT:

From the Test Screen, navigate to the Batch Data Screen and select product from dropdown display. Batch details are entered in the Test Screen. Open drawer, remove cap from bottles to expose induction seal and place into the machine nests. Close drawer.

2. TEST PROCESS

Press “Start Test”. The product nests automatically adjust to the size of the bottle and a vacuum is pulled. At the end of the test cycle the vacuum is vented. The force generated by the bottle is measured throughout this process.

3. RESULTS

The machine issues a PASS/FAIL result for each bottle depending on the force it has generated under vacuum. Graphical information along with batch data is available for every test.

MACHINE OPERATION

Test Methods are developed for each bottle size/shape and are stored as recipes for that specific bottle.

A COMPREHENSIVE RANGE OF PRESS OUT DEBLISTERING MACHINES THAT OFFER SPEED, EFFICIENCY AND SAFETY IN THE RECOVERY OF VALUABLE PRODUCT.

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3. PRODUCT RECOVERY

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3. PRODUCTRECOVERY

A COMPREHENSIVE RANGE OF AUTOMATIC, SEMI-AUTOMATIC AND MANUAL DEBLISTERING MACHINES THAT ENABLE THE SAFE RECOVERY OF VALUABLE PRODUCT FROM ALL TYPES OF REJECTED BLISTER PACK.

Sepha are the global leader in innovation and development of pharmaceutical deblistering equipment. Our machines are used globally on a daily basis by the majority of leading pharmaceutical companies to recover valuable product from blister packs.

All models in the Press-Out range allow rapid changeover and minimum downtime with maximum hygiene and efficiency. Using minimal pressure to extract tablets and capsules ensures that foil pieces do not detach from the blisters and prevents product damage during the deblistering process. Sepha has products suitable for push-thru blisters as well as childresistant or peelable blisters.

WHY RECOVER PRODUCT FROM BLISTER PACKS?

Blister packs are rejected because of: empty pockets; incorrect product; incorrect batch coding; leak test failure; and inventory changes. The recovered product can immediately be repackaged increasing production yields.

REDUCE WASTE DISPOSAL COSTS

It is generally less expensive to dispose of empty blisters than filled ones, so it makes sense to

separate active product from waste packaging before disposal.

ENVIRONMENTAL POLICY

Deblistering can help to meet legislative requirements whilst minimising the impactof manufacturing processes on the environment.

INVENTORY MANAGEMENT

Manage fluctuating market demands and organise inventory efficiently by emptying existing blister stocks and repacking products into alternative formats.

INCREASE STAFF MOTIVATION

Emptying blisters by hand is tedious and repetitive. Mechanical deblistering prevents sore or cut fingers, and reduces the risk of RSI or Carpal Tunnel Syndrome.

For more information on deblistering visitwww.sepha.com

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PRESS OUTMANUAL / MANUAL WIDE

MANUAL, SEMI-AUTOMATIC AND AUTOMATIC DEBLISTERING MACHINES FOR RECOVERING TABLETS AND CAPSULES FROM PUSH-THRU BLISTERS

PRESS OUT MANUAL / MANUAL WIDE / SEMI-AUTOMATIC / AUTOMATIC

PRESS OUT MANUAL/ MANUAL WIDE AND SEMI-AUTOMATIC

FEATURES & BENEFITS

• Portable & flexible - can be adjusted quickly to suit any push-thru blister pack

• Fully cGMP and easily cleaned

• Handles PVC/alu as well as alu/alu blisters

• Easy to use - no specialist skills needed

• Product recovered cleanly and hygienically

• Ideal for small batches

PRESS OUT AUTOMATIC

FEATURES & BENEFITS

• Automatic feed and user interface with fault indicators

• Fully cGMP & easy to use

• Variable speed up to 60 blisters per minute

• Handles PVC/alu as well as alu/alu blisters

• Low-cost Custom or adjustable tooling

• No product or foil contamination

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PRESS OUTSEMI-AUTOMATIC / AUTOMATIC

PRESS OUTMANUAL WIDE

PRESS OUTSEMI-AUTOMATIC

PRESS OUTAUTOMATIC

PRESS OUT MANUAL / MANUAL WIDE / SEMI-AUTOMATIC / AUTOMATIC

MACHINE OPERATION

PRESS OUT MANUAL/MANUAL WIDEBlister packs are manually fed through a set of rollers by turning a handle. The tablets or capsules are simultaneously removed from the blister pack and separated from the waste packaging.

MANUAL- In-line layout blisterMANUAL WIDE -Diagonal/Offset & In-line layout

PRESS OUT SEMI-AUTOMATICUses the same patented deblisteringmechanism as the Press Out Manual Wide,but is driven by an electrical motor allowing adeblistering rate of up to 30 packs per minute.

TOOLINGSingle set of adjustable tooling. Fast set-up within 1-2 minutes.

PRESS OUT AUTOMATICThe speed of the machine operation can bevaried to a maximum of 60 blisters per minute.

1. Blister packs are fed automatically from the magazine stack through a set of rollers.

2. The tablets or capsules are gently eased out of the blister and are collected separatelyfrom the waste packaging.

TOOLINGCustom tooling is required for each differentblister pack size. Format changeover, whichdoes not require tools, is fast and easy.

MANUAL, SEMI-AUTOMATIC AND AUTOMATIC DEBLISTERING SOLUTIONS FOR IN-LINE, DIAGONAL AND OFFSET LAYOUTS

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MANUAL MANUAL WIDE SEMI-AUTOMATIC AUTOMATIC

OPERATION Manual Manual Semi-automatic Automatic

BLISTER TYPE Push-thru Push-thru Push-thru Push-thru and Multi-product

BLISTER LAYOUT In-line In-line In-line and Diagonal / Offset In-line and Diagonal / Offset

PACK DIMENSIONS Max 120mm (4.7”) (W) Max 170mm (6.7”) (W) Max 170mm (6.7”) (W) Max 150mm (5.9”) (W)

Unlimited length Unlimited length Unlimited length Max 120mm (4.7”) (L)

CONSTRUCTION All product contact areas constructed from Stainless Steel (Grade 316) or ABS Food Grade

UTILITIES None required None required Electrical: 110/230V AC Electrical: 110/230V AC

Single Phase Single Phase

OPERATING SPEED Up to 20 blisters Up to 20 blisters Up to 30 blisters Up to 60 blisters

per minute per minute per minute per minute

MACHINE DIMENSIONS

Width 320mm (12.6”) 380mm (15”) 355mm (14”) 620mm (24.4”)

Depth 260mm (10.2”) 295mm (11.6”) 360mm (14.2”) 610mm (24”)

Height 210mm (8.3”) 230mm (9.1”) 240mm (9.4”) 1310mm (51.6”)

MACHINE WEIGHT 6.5kg (15lbs) 8kg (18lbs) 18kg (40lbs) 70kg (154lbs)

SHIPPING WEIGHT 8.5kg (19lbs) 11.5kg (25lbs) 28kg (61lbs) 140kg (309lbs)


PRESS OUTUNIVERSAL

FEATURES & BENEFITS

• Automated, variable speed control & operation setting

• Capable of removing product from child resistant packs

• Automatic feed

• Can deblister up to 50 blister packs per minute

• Handles all pack formats

• Integrated 316 Stainless Steel product collection bin

• Zero contamination levels

• Fully cGMP

• Sophisticated, easy to operate software control system

• Temperature and humidity monitoring option

• Easy access for fast cleaning and product changeover

Press Out Universal is the deblistering machine of choice for the world’s largest producers of pharmaceutical blister packs because of its quality, flexibility, speed and unrivalled product recovery rates.

FULLY AUTOMATED, HIGH SPEED DEBLISTERING MACHINE CAPABLE OF REMOVING PRODUCT FROM ALL TYPES OF BLISTER PACK MATERIAL, INCLUDING ALU/ALU AND CHILD RESISTANT PACKS.

PRESS OUT UNIVERSAL

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STAGE 1:Packs are loaded into a feeding magazine and then auto-fed to the integrated cutting station.

STAGE 2:The lidding material in each pack is precision cut around the base of each pocket using pack specific tooling to ensure zero product damage and contamination.

STAGE 3:The packs are then rotated to specific press out tooling where the product is gently pushed out into

the integrated, removable, 316 stainless steel collection bin. Product can now be safely returned to the production line for rework if required.

STAGE 4:Empty blister packs are rotated to a separate removable waste bin for disposal.

TOOLING

Custom tooling is supplied for each different pack size with fast delivery times.

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SOPHISTICATED, GENTLE CUTTING TECHNOLOGY MAKES IT IDEAL FOR RECOVERING HIGH VALUE, FRAGILE TABLETS AND CAPSULES AT A RATE OF UP TO 50 BLISTER PACKS PER MINUTE.


UNIVERSAL

OPERATION Automatic

BLISTER TYPE Push-through, Child-resistant, Peelable & Multi-product

BLISTER LAYOUT All

PACK DIMENSIONS Min 65mm(2.6") Max 105mm (4.1") (W) Min 30mm (1.2") Max 140mm (5.5") (L)

CONSTRUCTION Stainless Steel (Grade 316 & 304)

USER INTERFACE 5.7" Colour TFT Touchscreen HMI

UTILITIES Electrical: 110/230V AV Single Phase

Air Supply: 6 Bar

OPERATING SPEED Up to 50 packs per minute

TOOLING CHANGEOVER 5 minutes

MACHINE DIMENSIONS

Width 965mm (38”)

Depth 665mm (26.18”)

Height 1540mm (60.6”)

MACHINE WEIGHT 230kg (507lbs)

SHIPPING WEIGHT 330kg (728lbs)


MACHINE OPERATION

Products are recovered with zero shard contamination or product damage during a rapid 4 stage operation.

PRESS OUTUNIVERSAL MINI

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AUTOMATED DEBLISTERING MACHINE FOR RECOVERING LOW VOLUMES OF PRODUCT FROM ALL BLISTER PACK TYPES, INCLUDING CHILD-RESISTANT PACKS

PRESS OUTUNIVERSAL MINI

FEATURES & BENEFITS

• Deblisters at a speed of up to 16 packs per minute

• Bench top unit with small footprint

• Capable of recovering tablets and capsules from peel-able and child resistant blister packs

• Automatic feed

• Simple operation via Allen Bradley touchscreen HMI

• Simple, fast tooling setup and changeover

• Easy access for cleaning

• Fully cGMP

• Zero contamination levels

• Low cost tooling

• Mobile workstation available as an optional extra

Press Out Universal Mini is a low volume, bench top, automated deblistering machine designed specifically for recovering short runs of valuable and fragile product from all types of blister packs including child resistant, senior friendly, paper backed and alu/alu packs.

Press Out Universal Mini uses simple, low-cost tooling that is easy to change over and prevents product damage and contamination. It is designed specifically for short production runs and multiple product changeovers.

STAGE 1: Packs are loaded into the magazine. Each pack is then fed into the locating tool and held in place using vacuum.

STAGE 2: The pack is rotated and clamped into place. The lidding material of each blister cavity is precision-cut around the edge using specific tooling to prevent product damage and contamination.

STAGE 3: The products are then gently pressed out of the pack and into the removable collection bin. The empty blister packs are collected in a separate waste bin.

TOOLING Custom tooling is supplied for each differentpack size with fast delivery times.

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Operation Automatic

Blister Type Push-thru, Child-resistant, peel-able & Multi-Product

Blister Layout All

Pack Dimensions Max 105mm (4.1”) (W)

Max 140mm (5.5”) (L)

Construction Stainless Steel (Grade 316 & 304)

User Interfaces 3” Monochrome Touchscreen HMI

Utilities Electrical: 110/230V AC Single Phase

Air Supply: 6 Bar

Operating speed Up to 16 Packs per minute

Tooling changeover 5 minutes

Machine Dimensions Width 615 mm (24.2”)

Depth 555 mm (21.9”)

Height 688 mm (27”)

Machine Weight 62.5 kg

Shipping Weight 112.5 kg

Warranty Supplied with a 12 month warranty.

(Service Level Agreements and/or extended warranties are available for additional support).

THE SOPHISTICATED UNIVERSAL CUTTING TECHNOLOGY HAS BEEN ADAPTED TO ALLOW RECOVERY OF LOWER VOLUMES OF VALUABLE PRODUCT FROM ANY BLISTER PACK.

MACHINE OPERATION

Fragile products are recovered from any type of blister pack in short runs during the following 3 stage process.

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WHICH PRESS OUT?QUICK REFERENCE TABLE

BLISTER PACK TYPE

(Perforated and Imperforated)

PUSH-THRU

PVC/Alu

PVDC/Alu

PP/Alu

ACLAR/Alu

Alu/Alu

CHILD-RESISTANT

Push-Thru

Peelable

DIAGONAL /

OFFSET

MULTI-PRODUCT

In-line

Staggered

CIRCULAR

PRESS OUTMANUAL

PRESS OUTMANUAL

WIDE

PRESS OUTSEMI

AUTOMATIC

PRESS OUTAUTOMATIC

_ _ _ _

_

_ _ _ _

PRESS OUTUNIVERSAL

_ _ _ _

_ _ _ _

PRESS OUTUNIVERSAL

MINI

INITIAL CONSULTATIONBefore purchasing a machine from Sepha we will work with you to ensure that the product, and associated tooling, meets your needs and is designed to meet your specific production requirements.

INSTALLATIONAll machines are supplied with comprehensive documentation and an Instruction Manual. We also provide on-site training or a demonstration video.

VALIDATIONIf required, validation assistance can be given in the form of protocols to be completed by the end user.

TECHNICAL & CUSTOMER SUPPORT SERVICESExperienced staff are available at all times to provide a high level of support and advice on a wide range of technical and pharmaceutical processing and production issues.

_

All Sepha products are covered by patents, registered trade marks or copyrights. All Sepha machines conform to CE certification requirements.

MAINTENANCE-FREE OPERATIONSepha EZ Blister, Press-Out and Medpak machines are virtually maintenance-free, requiring only cleaning. All parts to be cleaned are easily removed from the unit and can be thoroughly washed in hot water and dried at elevated temperatures.

WARRANTY All machines and component parts are supplied with a 12 month warranty (including labour) applicable from date of installation. This excludes normal wear and tear or loss of parts.

EXTENDED WARRANTY We offer an extended warranty plan that extends the initial 12 month warranty. This service includes customer and machine specific service level agreements, on call service plans and tele-support plans.

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CUSTOMER SERVICE AND CUSTOMER CONFIDENCE IN OUR PRODUCTS IS AT THE CORE OF THE SEPHA BUSINESS. WE WANT TO ENSURE THAT OUR CUSTOMERS BUY THE CORRECT PRODUCT FOR THEIR NEEDS AND THAT THEY ARE FULLY TRAINED IN HOW TO OPERATE OUR EQUIPMENT. IF SOMETHING SHOULD GO WRONG, WE HAVE A FAST, QUALITY RESPONSE AVAILABLE FROM OUR SERVICE ENGINEERS AND PARTNERS.

CUSTOMER SERVICE

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TASI PROVIDES TEST, MEASUREMENT, INSPECTION AND ASSEMBLY SOLUTIONS WHICH IMPROVE MANUFACTURING PROCESSES AND BRING VALUE-ADDED RESULTS VITAL IN TODAY’S GLOBAL BUSINESS ENVIRONMENTS

TASI GROUP

ABOUT TASI

TASI Group is a world leader in advanced test and inspection instrumentation & systems, flowmeters and flow control products, measurement instrumentation and automated assembly and test systems.

The TASI Group of Companies is comprised of three technologically advanced Strategic Business Segments (Test & Inspection Solutions; Flow Measurement Solutions and Assembly & Test Solutions).

TASI TEST & INSPECTION SOLUTIONS

In 2013 Sepha became part of the the TASI Test & Inspection Strategic Business Segment. The Test & Inspection segment is a global provider of product testing, inspection and quality solutions for a wide range of manufacturing operations. Comprised of four businesses with facilities in North America, Europe and Asia, we provide instrumentation, test machines, and engineered systems to a diverse global customer base.

Test & Inspection Group Companies

Test & Inspection Technologies Include:• Laser Inspection• Pressure / Vacuum Decay• Differential Pressure• Mass Flow• Occlusion• Assembly Verification• Functional Testing• Helium Mass Spectrometer• Visual Inspection

Major Markets Served• Pharmaceutical• Medical Devices• Plastics• Packaging• Automation• General Industrial Products• Food & Beverage• Appliance• Consumer Product

Founded in 1974 Bonfiglioli Engineering, headquartered in Italy, is a world leader in the design and manufacture of Leak Testing, Visual Inspection and Head Space Gas Analysis (HGA) equipment for a diverse range of industry sectors such as; Pharmaceutical, Metal Cans, Aerosols, Chemical & Cosmetic, Plastics and Food & Beverage.

INSPECTION METHODS

Leak Testing

• Vacuum Decay Method

• Pressure Decay Method

• Lid Deflection

• Force Decay

Visual Inspection

• Foreign Particles

• Cosmetic Defects

• Cap Inspection

• Other Visual Inspection

Head Space Gas Analysis (HGA)

• Oxygen Level Analysis

• Moisture Level Analysis

LEAK TESTING INSPECTION SOLUTIONS INCLUDE:

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ABOUT BONFIGLIOLI ENGINEERING

Lab-Scale In-Line Combined Systems

Sepha LtdUnit 25Carrowreagh Business ParkCarrowreagh Road, DundonaldBelfast BT16 1QQNorthern IrelandUnited Kingdom

T: +44 (0)28 9048 4848F: +44 (0)28 9048 0890E: [email protected]

www.sepha.com

Revised 03/2015

innovators of specialised equipment for … · innovators of specialised equipment for package leak...

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