Lifetime Services

Delivering Solutions – Application Expertise

We are thoroughly familiar with your products and appli-cations! Romaco specialises in engineering technologies for solid pharmaceutical dosage forms. Our concepts and system solutions are inspired by the rich experience and know-how of our 600-strong team of employees.

Creating Value – Enhanced Performance

Profit from Romaco’s excellent value for money! We help you optimise your OEE balance systematically. With our efficient production and service manage-ment, we cut the running costs for your machines and increase your output in the long term.

Exploiting Technologies – Product Diversity

Our product diversity knows no bounds! The modular concept behind Romaco machines and equipment is the key to your success. With seven product lines, we are in a position to respond promptly and flexibly to changing market requirements. Together we are stronger!

Installation & Commissioning• Commissioning of each machine

is followed by a SAT based on the agreed criteria

• Perfect installation of the individual machines

• Coordinated commissioning and initial briefing for operators

Romaco Services Make Life Easier – Throughout the Entire Lifespan

Thanks to our reliable after-sales service and intensive, demand-oriented support, Romaco customers are assured a maximum return on investment. Qualified staff are at hand quickly and flexibly around the clock, whatever your problem. Customer support, format parts, retrofits & upgrades and spare parts are all part of the Romaco portfolio. Romaco’s modular retrofit and upgrade kits are optimally matched to one another, adding even more value for our customers.

Ramp-Up Support• Active support during the ramp-up phase:

shorter ramp-up period• Ongoing support from our maintenance

and operating personnel enables problems to be recognised and solved early on

Project Phase

Romaco Systems and Services life cycle value

Order SAT

Prod

uctiv

ity

Ramp-Up Phase Production Phase

Service Solutions Lifetime

typical life cycle returnvalue added through Romaco beyond technology

Seminars and technology consulting Retrofit and upgrade

Ramp-up support Maintenance

Calibration serviceQualification support

Spare parts and formatsInstallation and start up

Remote support and hotline

OEE support

Training

Qualification Support• Documentation by Romaco specialists• Qualification documentation is continu-

ously adapted to the latest rules and regulations

Delivering Solutions

Training• Modular training concept• GMP compliant training courses with

subsequent examination and certification• Hands-on shop floor training

Project Phase

Romaco Systems and Services life cycle value

Order SAT

Prod

uctiv

ity

Ramp-Up Phase Production Phase

Service Solutions Lifetime

typical life cycle returnvalue added through Romaco beyond technology

Seminars and technology consulting Retrofit and upgrade

Ramp-up support Maintenance

Calibration serviceQualification support

Spare parts and formatsInstallation and start up

Remote support and hotline

OEE support

Training

Calibration Service• Highest levels of quality and OEE main-

tained• Compliance with all stipulated regulations• All necessary calibration documents

included

Maintenance• Annual preventive audit• Extended warranty for up to four years• Flat rate charge for spare parts kits• Flexible maintenance contract modules

Remote Assist• Remote maintenance via a secure

connection between your machine and the Romaco support centre

• Technical telephone support to fix faults and answer questions

OEE Support• Higher output of good products• Implementation plan for process im-

provements based on lean modules and machine modifications

Project Phase

Pellet homogeneously coated in a VENTILUS®

Simulation of the distribution of the spray medium

ROTOJET® spray nozzle

For reproducible drying, granulation and coa-ting processes, we recommend carrying out these tests at our Romaco Innojet InnoTech test centre in Steinen. Our laboratory experts will be happy to assist you whenever you need them.

Profit from our competent advice when preselecting and procuring the necessary test materials.

The fully functional processing machines enable you to try out different parameter settings.

Don’t just take our word for it, see for your-self – and experience our air flow bed tech-nology live!

InnoTech ServicesAll tests carried out are documented in detail.

The following process steps can be per-formed in our laboratory:• Drying• Granulation• Coating• Hot melt coating

Since our laboratory equipment is fully functional, we can also support you with scale-ups to real production conditions.

All process steps are possible using a single product container, which does not need to be changed.

Customer Benefits• Competent advice and implementation

support• Efficient selection of test materials means

lower costs• Fully functional processing machine using

just one container• Air flow bed technology enables optimal

fluidisation of solid particles• Continuous monitoring and analysis of

product behaviour throughout the process• Insight into our uniform coating technology

improves product quality and reduces spray loss

Project Phase

Product analysis of physical material properties

Pressure measuring for scale up testsDebriefing after workshop

The KiTech test laboratory in Cologne is a platform for getting to know the various technologies of Romaco Kilian. In the KiTech laboratory, customers can streamline their tableting processes and systems by testing processes and products, optimise flow properties or filling behaviour, create test batches and perform scale-up or project studies. Romaco Kilian supports its users with competent advice when it comes to optimising the tableting process or trouble- shooting during tablet manufacturing.

KiTech Services• Six fully equipped press rooms and

three conference rooms• Romaco expert team made up of appli-

cation specialists and pharmacists• Compression tests with standardised

result reports• Feasibility studies for a wide range

of granulates• Scale-up analyses and simulations of

customer products• Verification of scale-up results on pro-

duction presses• Process and application studies for

customer products

Customer Benefits• Product behaviour testing• Minimised risk when selecting the

most suitable tablet press• Optimised OEE• Direct access to all areas of knowledge• Insights into the latest machine features

from Romaco Kilian

The Macofar test centre and cleanroom at the Romaco facility in Bologna is a classi-fied, air-conditioned area with a controlled room temperature and relative humidity. The air-conditioning system enables the environment in each customer’s production area to be reproduced.

Powder filling tests can thus be performed with the most accurate possible results. The air in the cleanroom is filtered by HEPA filters installed in the ceiling. An alarm system mon-itors the cleanroom to prevent unauthorised access.

Customer Benefits• Exceptional dosing accuracy• Verified powder flow properties• Test powder has optimal hygroscopicity• Dosing process optimised based on the

powder characteristics• Optimum powder formulation enables

maximum filling performance

Romaco customers searching for the most appropriate solution to meet their specific production needs profit not only from next-generation Macofar machines but also from the competent support of an engineering team with extensive know-how and experi-ence in powder filling.

Project Phase

Romaco Bologna Cleanroom for powder filling tests

High speed powder filling and capping solu-tions for sterile applications

Vacuum-pressure technology for powder filling

Model of biaxial material forming Inspection of the sealing roller with microscope

Blister tightness test

At its PacTech technology centre in Karlsruhe, Romaco analyses and optimises primary packaging in cooperation with users and packaging manufacturers. Our custo-mers benefit from the advice of our expe-rienced application specialists as well as comprehensive support when choosing the most suitable primary packaging solution.

PacTech Services• Damage analyses geared to practical

requirements and assistance with root cause investigations or troubleshooting primary packaging problems

• Joint definition of a practical approach• Network of independent experts draw

up reports which will be admitted in court

Project PhaseCustomer Benefits• By selecting the packaging early on prior

to registering the product, unforeseen consequential costs or production problems can be avoided

• By optimising the packaging materials and sealing tools, you can improve the OEE and cut the costs for packaging materials

• By analysing samples upfront, you can carry out a reference analysis in case of damage

Ever shorter times to market mean special challenges during the ramp-up phase. Valu-able opportunities can be lost due to internal coordination issues and optimisation loops. Romaco helps customers conduct the ramp- up phase under ideal conditions. Compre-hensive consulting and shared know-how significantly reduce the ramp-up period, and with it the costs for commissioning a new machine or line.

Planning• Foresighted overall project planning• Regard for future developments• Early involvement of specialists

Ramp-Up Phase

Execution• Qualified support during the implemen-

tation• Capability transfer managed by an experi-

enced team of experts• Lean production without cost-intensive

post-optimisation

Optimisation• Process improvements, e.g. retooling of

the machine according to lean principles• Early detection of process errors facilita-

tes prompt correction

Customer Benefits• Full availability as planned• Reduced time and costs: quicker payback• Optimised processes from the very start• Compliance with target capacities

Project phase

value added through Romaco beyond technology

Order SAT

Prod

cktiv

ity

Ramp-up phase Production phase

typical life cycle return

OEE = f{availability, performance, quality}

Romaco Systems and Services life cycle value

Planning

Realisation

Optimisation

Audit

Improvements

Follow-up

Service Lifetime Solutions

OEE Audits• OEE audits: lean expertise combined

with technical system know-how • Losses visualised together with their

causes• Optimisation plans graphically repre-

sented

Improvements • Organisational and technical improve-

ments formulated and implemented• More efficient retooling process taking

account of breaks and cleaning times• Micro stops and NOK products avoided

Follow-Up• Continuous follow-up: control over the

implementation and optimisation of im-provements

• Kaizen management, ongoing efforts to reduce production time, costs and errors

Production Phase

During the production phase, companies face the major challenge of ensuring consis-tently high overall equipment effectiveness (OEE). The OEE concept enables daily losses and their causes to be identified. Romaco customers profit from professional support using lean management tools. Excellent OEE values are achieved in this way.

Customer Benefits• Improved production and capacity

planning• Cost savings result in a competitive

advantage

Project phase

value added through Romaco beyond technology

Order SAT

Prod

cktiv

ity

Ramp-up phase Production phase

typical life cycle return

OEE = f{availability, performance, quality}

Romaco Systems and Services life cycle value

Planning

Realisation

Optimisation

Audit

Improvements

Follow-up

Service Lifetime Solutions

Good training lays the foundation for better OEE. Our broad array of training opportuni-ties is aimed at both operators and mainte- nance personnel. A balanced mix of theory and practice is fundamental to long-term training success. Experienced instructors, well-equipped seminar rooms and GMP compliant materials form the basis for ef- fective training.

Our Range of Services• Training calendar with standardised

training courses of varying degrees of difficulty

• Seminars with external experts, e.g. tab-leting and granulation seminar with JRS

• Directly on the customer’s premises or at a Romaco facility (several technical labora-tories worldwide)

• Training materials, certificates of atten-dance

• Other training programmes– For operators– For maintenance personnel– How to optimise a machine’s per-

formance

Customer Benefits• GMP compliant materials• Employees learn how to recognise

errors earlier• Better OEE• Regular monitoring of knowledge levels• Customised training concept with modu-

lar contents

Training

Class room Discussion sessionTraining at the machine

Remote AssistRomaco Remote Assist provides a simple and secure way to diagnose problems with your machine from a distance. If an issue arises, you set up a secure VPN connection and our hotline experts can start trouble-shooting immediately. The time and expense which are normally inevitable to travel to your factory are saved. You, the customer, decide which components can be accessed by the technician at the other end of the line. No unnecessary delays are incurred.

Services• Telephone support in real time• Expert hotline speeds up troubleshooting• Remote connection enables machine

parameters to be diagnosed and checked online

• Call4Service function guarantees instant support

• Smart glasses allow our experts to join you on the machine in real time

Customer Benefits• No delays waiting for a service

technician to arrive• No additional travel expenses

Smart glasses at customer site Hotline technician workplaceSee through screen of the Smart glasses

Regulative requirements

Quality management

Production

• Extended service life: replacement of commercial components that are no longer supported by the manufacturers

• Increased flexibility: ability to respond quickly to new market conditions• Higher quality and output: modernised drive systems or improved product feeding

• Optimal process reliability: trouble-free operation based on specified parameters with non-conformances reduced to a minimum

• Recording and provision of all process data: robust statements regarding product and packaging quality

• Special protection: essential for products which are sensitive to oxygen, light or humidity

• Supply chain security (track & trace): unique iden- tification code on the secondary packaging

• Code legibility check with subsequent data storage

• Electronic signature and recording (Part 11) by validated, computerised systems

Production Phase: Challenges

Regulative requirements

Quality management

Production

Booklet Feeder Upgrade Kit for automatic feeding of instruction leaflets of any size at high speed

PLC & HMI Upgrade Kit for electrical hardware ensures full availability of spare parts

New Feeding System enables reliable product feeding, even with complex geometries

Main & Upstream Pressure Roller Upgrade Kit extends the service life of the rollers on tablet presses

Sealing Force Control Upgrade Kit provides a tighter blister seal

Tablet Press Control Upgrade Kit promises consistently high product quality

Nitrogen Flushing Upgrade Kit prolongs the product shelf life

Panel Software Upgrade Kit achieves compliance with FDA CFR Title 21 Part 11 and better ease of use

Mark & Verify Upgrade Kit applies codes to sec- ondary packaging – implementation of coding and

verification in cartoners as an option

Glue Upgrade Kit (Tamper Evidence) pre-serves the integrity of tamper-proof seals by

retrofitting glue applicators to the cartoners

Production Phase: Solutions

QuickFeed – Change of the feeding unitwithin seconds

Feeding roller of the blister machineRomaco Noack 960

Punch/Die with extended durability

Original Romaco Parts Last LongestOriginal formats from Romaco are reliable, high-precision parts which are specially developed for each individual customer’s machine, product and packaging. They have a direct impact on the effective machine cycle times as well as on product quality. We come up with the perfect solution for high output and short retooling times regardless of the material and specification. Romaco also offers a wide range of related services and product options beyond the actual format parts.

Romaco Format Service• More than 40 years of experience

making format parts • One hundred percent quality control• Fast track service• All format parts are comprehensively

tested at our format centre before they leave the factory

• Machine parameters and qualification documentation included in the scope of supply

Formats Customer Benefits• Professional consulting from PacTech

upports the selection of the most suitable format

• Technology and functionality you can rely on

PartGuard Die tableSpray nozzle ROTOJET®

Lifelong AvailabilityThe use of third-party components can often be a cause of complications, leading to production stoppages. With original spare parts from Romaco, consistently high pro-duct quality and productivity are assured. These high-tech, GMP compliant parts are tailor made for the specific requirements of Romaco machines. Romaco promises to ship original spare parts to you promptly, whether for a new machine or for an older model. There is no need to invest in a large stock of your own.

Romaco Solutions Help Streamline Your Spare Parts Store• Defined spare parts kits for regular

maintenance• Selected parts also available as reinsur-

ance components• Specially defined kits for commissioning• Tailor-made replacements for discontin-

ued parts• Decentralised storage facilities ensure

that parts are available locally

Spare PartsCustomer Benefits• Short installation and assembly times• All spare parts available for a minimum

of ten years• Durable parts that fit precisely• Short response and delivery times

Creating Value

• Less downtime because our technicians provide rapid support

• Quick response from the expert hotlines at our production facilities

• Internal training system ensures the highest level of technical know-how

• Hotline ticket system guarantees an answer to every question

Customer Support

Technology and Training Centres

• Interdisciplinary knowledge is shared with customers

• Development in cooperation with packaging manu-facturers enables access to all the latest insights

• Continued optimum support is possible and ensured in case of problems

• Obsolescence management safeguards com- ponent replacements

Retrofits & Upgrades

• Only minimal downtime because Romaco also stocks reinsurance components

• Precisely fitting parts reduce product loss• Where possible, components discontinued by

third-party manufacturers are replaced one to one

Spare Parts / Formats / Compression Tooling

Romaco Sales & Service centers

Agents with certi�ed service support

Production & Spare parts centers

Romaco Germany Cologne Romaco Italy Bologna

Romaco GermanyHeadquarter Karlsruhe

Romaco Germany Steinen

Decentralized organisation

Romaco USARomaco France

Romaco Brazil

Romaco China

Romaco Russia

Romaco India

2018

/ 06

Romaco GroupAm Heegwald 1176227 KarlsruheGermany

P +49 (0)721 4804 0F +49 (0)721 4804 211E service@romaco.com

www.romaco.com