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Final MI Feb Main Doc     30/1/12     3:04 pm     Page 7




                                                                                                                       Pharmaceuticals




           Rottapharm Management Category winner for MEETA Maintenance and Asset Management Awards 2011 Paperless Maintenance
           Project - Pictured (l-r) are Noel O’Regan, PMI; Darren O’Shea, Rottapharm; Wesley Horan, Rottapharm; Brian Dunne, Rottapharm
           and John Coleman, MEETA




           Rottapharm Madaus
           Starts as it Means to Go On
           In just over a decade Rottapharm has made a huge impact on the pharmaceutical
           manufacturing landscape in Ireland, and now its methods of production is
           gaining industry recognition also.
                 he company employs                                         ification for the production      choice to be administered

          T      150 people at the
                 Mulhuddart facility, of
           which about 60 work in
                                                    “These
                                                successful
                                                                            of medical devices.

                                                                            Manufactured
                                                                                                              as early as possible in the
                                                                                                              treatment of osteoarthritis.
                                                                                                              Bromelain tablets, an anti-
           production. Currently the          initiatives are               Products                          inflammatory product, a
           plant produces 350 million                                          The operation in west          sustained release capsule
           sachets and over 450 mill-         attributable to               Dublin manufactures a             formulation of Aspirin and
           ion capsules/tablets, which                                      range of capsule, sachet          the laxative Plantago Ovata
           is over four times the amount         a growing                  and tablet formulations in        sachets are also manufac-
           produced when the com-                                           addition to the API Cryst-        tured on site.
           pany set up in Ireland in               team of                  alline Glucosamine Sulph-
           1999.                                                            ate. The company’s leading        Successful
              The plant obtained auth-           dedicated,                 product DONA (the original        Investment
           orisation to produce phar-                                       Glucosamine Sulphate) is            In 2009 Rottapharm ann-
           maceutical specialities of
                                               talented and                 manufactured in sachet            ounced that it was under-
           the Irish Medicines Board               flexible                 and capsule forms for mar-        taking a €7 million invest-
           in January of the following                                      kets in Europe, Asia and          ment project. This was
           year. That same year, it             personnel”                  South America.                    completed in 2010 and the
           obtained the ISO 9002 cert-                                         DONA is the drug of first      investment involved the
                                                                                                           Manufacturing Ireland Feb 2012    7
Final MI Feb Main Doc     30/1/12     3:04 pm     Page 9




                                                                                                                       Pharmaceuticals

           transfer of a number of
           new processes from anoth-
           er facility within the group.
           The project resulted in an
           additional four packaging
           lines, two coating systems
           and an encapsulation mach-
           ine.
              The volumes of finished
           product packaged doubled
           as a result and an addition-
           al 35 new jobs were creat-
           ed. Rottapharm now has
           five sachet lines, two blis-
           ter lines and two bottling
           lines in the packaging area.
           Factory costs have risen by
           only 12 per cent - with this
           increase in packaging vol-
           ume.

           Standing Alone
              Rottapharm are currently     Rottapharm Certificate of Excellence winner for MEETA Maintenance and Asset Management
           processing 46,000kg of          Awards 2011 Sachet line 6 TPM Project - Pictured (l-r) are Noel O’Regan, PMI; Ray Burtenshaw,
           material per week within        Rottapharm; Bella Busko, Rottapharm; Aleksandra Wietrzyk, Rottapharm; Richard Hayes,
           their manufacturing areas       Rottapharm; John Coleman, MEETA; Conor Campion, Rottapharm and Cormac Quaid, Rottapharm
           which encompasses API
           and bulk solid dosage inter-                                    been completed.                    from each area of the fac-
           mediates. This represents
                                                 “We have                     The plant dehumidifica-         tory. The use of net presen-
           a 50 per cent increase on                                       tion system was re-engin-          ter on personnel comput-
           manufacturing volumes                 had great                 eered to supply dehumidi-          ers and bulletin boards in
           since 2008.                                                     fied air to process equip-         various locations on site
              Rottapharm Madaus dis-          success with                 ment rather than to pro-           ensures employees are
           covers, develops and com-                                       cess rooms. As result there        aware of the on-going
           mercialises a range of                                          is now one dehumidifier            energy projects.
           products for the treatment             the Irish                supplying four sachets
           of anti-inflammatory, anti-                                     lines where previously             Industry Recognition
           rheumatic, bone metabo-               operation                 there was two dehumidi-               “All companies like to
           lism, menopausal and gas-                                       fiers supplying two sachet         win awards and be recog-
           tro-intestinal disorders. To                                    lines. Electricity usage in        nised for projects that they
           date research activity has
                                               over the last               2011 was reduced by 20 per         completed. It’s important
           generated about 300 pat-                                        cent compared to 2010.             for the team members to
           ents and 19 new drugs.             13 years and                    Planned projects for 2012       feel that they are part of a
                                                                           include the installation of        growing and reputable
           Energy Efficiency                    we are very                control software on two            company that can compete
              In terms of operations                                       chillers units along with a        and win awards against
           Rottapharm is very dedi-                                        site wide installation of LED      stiff opposition.”
           cated to energy efficiency         pleased with                 lighting. In addition, it is          “We consistently look for
           and green energy cost cut-                                      planned to use the heat            new ways to reduce ener-
           ting programmes. Energy            the initiatives              generated from a Regen-            gy costs, not just with gas
           efficiency projects became                                      erative Thermal Oxidiser to        and electricity but with
           a major part of Rotta-                                          heat water in a heat               water and waste saving
           pharm’s focus in recent
                                             undertaken in                 exchanger and pump the             projects too. Recently a
           times in a drive to improve                                     water back to the boiler           project was initiated inv-
           cost competitiveness. In           the pursuit of               room to pre-heat the return        olving the EPA Green
           the past few years major                                        MPHW to the boilers. A             Business Programme where
           projects on the HVAC sys-            operational                cross-departmental envi-           we are looking at recycling
           tem, lighting arrangements,                                     ronmental and energy team          water from the effluent
           boilers and the building                                        is in place, which helps           tank where the process
           management system have             excellence”                  gather energy saving ideas         water is treated and also
                                                                                                           Manufacturing Ireland Feb 2012    9
Final MI Feb Main Doc      30/1/12      3:04 pm     Page 11




                                                                                                                       Pharmaceuticals

                                                                                                              ines a range of KPIs were
                                                                                                              formulated for perform-
                                                                                                              ance reviews.
                                                                                                                 “We have seen a sub-
                                                                                                              stantial reduction in equip-
                                                                                                              ment failure rates plant
                                                                                                              wide since the system
                                                                                                              went live. The linking of
                                                                                                              Barco and PEMAC will also
                                                                                                              facilitate the introduction
                                                                                                              of meter based mainte-
                                                                                                              nance with actual running
                                                                                                              times determining routine
                                                                                                              maintenance requirements,”
                                                                                                              said Wesley Horan, Project
           A view of the Rottapharm facility in Mulhuddart, Dublin                                            Manager CMMS.
                                                                                                                 “The paperless mainte-
           the retentate from the puri-                                      to support timely and accu-      nance system compliments
           fied water loop. We will
                                                   “We have                  rate information about           the MES system installed in
           make a submission in res-                seen a                   maintenance activities. The      production and the ware-
           pect of the SEAI energy                                           system was installed and         house last year. We now
           awards next June. The obj-             substantial                validated to CFR 21 stan-        have electronic batch
           ective is not to waste energy                                     dards within six months          records instead of paper
           - if we get recognition for           reduction in                with data access and input       batch files on all of our
           our endeavours through                                            via military standard lap-       packaging lines and 90 per
           national awards that’s an              equipment                  tops at the machines.            cent of our manufacturing
           added bonus,” said Conor              failure rates                                                areas. The Werum MES
           Campion, Facilities Manager.                                      Maintaining                      system, which took two
              Since the commencement              plant wide                 Performance                      years to roll out plant wide,
           of manufacturing opera-                                             This system enabled            has delivered significant
           tions in 1999 the plant has             since the                 maintenance activities to        efficiency gains in produc-
           received many awards                                              be logged as they happen.        tion and quality assurance.
           including the Sustainable             system went                 In conjunction with a Barco      Paper has all but disap-
           Building Award, NISO Occ-                                         OEE system which is uniq-        peared within the engi-
           upational Safety Award,
                                                     live”                   uely integrated into mach-       neering and production
           Excellence Through People
           Gold Standard and now the
           MEETA awards.
              “We were delighted to
           win two awards for mainte-
           nance excellence at the
           annual MEETA awards run
           by Engineers Ireland last
           November. It was the first
           time we had entered for the
           awards. Our Paperless
           Maintenance project won
           first prize in the Mainten-
           ance Management category
           whilst we were awarded a
           Certificate of Excellence
           for our TPM project,” said
           Pat Garrahy, Managing
           Director.
              The Paperless mainte-
           nance project involved the
           installation of a comput-
           erised maintenance man-
           agement system called
           PEMAC from PMI Software           An encapsulation machine in operation

                                                                                                           Manufacturing Ireland Feb 2012     11
Final MI Feb Main Doc       30/1/12      3:04 pm      Page 13




                                                                                                              Pharmaceuticals

                                                                                                     The sustained engagement
                                                                                                     of our personnel with con-
                                                                                                     tinuous improvement is
                                                                                                     directly linked to business
                                                                                                     performance. The involve-
                                                                                                     ment of employees at all
                                                                                                     levels has brought about
                                                                                                     cost reductions, improved
                                                                                                     productivity and increased
                                                                                                     compliance. We have plac-
                                                                                                     ed great emphasis on
                                                                                                     employee empowerment,
                                                                                                     leadership behaviours and
                                                                                                     clear communication under-
                                                                                                     pinned by a common vision
                                                                                                     to drive all our CI activities”.
                                                                                                        Rottapharm Madaus is
                                                                                                     an Italian multinational
                                                                                                     group headquartered in
                                                                                                     Monza, Italy. It employs
                                                                                                     more than 2,000 people
                                                                                                     worldwide. It is active in
                                                                                                     about 85 countries world-
                                                                                                     wide and has manufactur-
                                                                                                     ing sites in Ireland, Italy,
                                                                                                     India, Germany and Spain.

                                                                                                     Looking to
           A sachet line in operation in the new facility                                            the Future
                                                                                                        The company aims to
           environment because of                                  lines in the plant with OEE       grow its contract manufac-
           the MES and CMMS pro-
                                                        “All       averaging 68 per cent.            turing business for sachets
           jects,” said Paul Ludorf,               companies          The project created a          in the coming years. Comp-
           Technical Manager.                                      sense of equipment owner-         letion of a new process
                                                    like to win    ship between production           development laboratory
           Performance                                             and maintenance person-           later this year will support
           Standards                                   awards      nel by working together to        this aspect of the Rotta-
              The strategy for operat-                             establish the correct pro-        pharm Ireland business.
           ional excellence was rolled
                                                       and be      cesses and practices. We             Rottapharm aims to inno-
           out when the new 2,000 sq               recognised      have now incorporated             vate continuously, combin-
           metre facility was opened                               TPM into our continuous           ing CI programmes with a
           for production and since                for projects    improvement programme.            strong technology platform,
           then, the processes put in                              This year we plan to have         to position the company for
           place by management, and                   that they    70 per cent of all employ-        future growth.
           adhered and added to by                                 ees participating in CI              “We have had great suc-
           staff, has garnered the
                                                 completed. It’s   teams rising to 100 per cent      cess with the Irish opera-
           praise of Rottapharm’s peers.          important for    in 2013,” said Richard            tion over the last 13 years
              “Our TPM project was                                 Hayes, Continuous Improve-        and we are very pleased
           initiated in July 2010 on a                the team     ment Manager.                     with the initiatives under-
           fully automated sachet fill-                                                              taken in the pursuit of oper-
           ing and packaging line. The             members to      United Team                       ational excellence. It is
           project team of production                                 Pat Garrahy explained,         planned to replicate the
           and maintenance personnel
                                                  feel that they   “These successful initia-         continuous improvement
           followed a nine-step imp-               are part of a   tives are attributable to a       model deployed in Dublin to
           rovement plan, which inv-                               growing team of dedicated,        other production plants
           olved significant capital              growing and      talented and flexible per-        within the Rottapharm
           investment in refurbish-                                sonnel who have demon-            Madaus Group,” Dr Enzo
           ment. At the end of the pro-              reputable     strated great commitment          Lacchini, Corporate Tech-
           ject the line was one of the                            to working together for           nical Director, Rottapharm
           best performing packaging
                                                    company”       improved site performance.        Madaus.
                                                                                                  Manufacturing Ireland Feb 2012        13

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Manafacturing ireland article 1

  • 1. Final MI Feb Main Doc 30/1/12 3:04 pm Page 7 Pharmaceuticals Rottapharm Management Category winner for MEETA Maintenance and Asset Management Awards 2011 Paperless Maintenance Project - Pictured (l-r) are Noel O’Regan, PMI; Darren O’Shea, Rottapharm; Wesley Horan, Rottapharm; Brian Dunne, Rottapharm and John Coleman, MEETA Rottapharm Madaus Starts as it Means to Go On In just over a decade Rottapharm has made a huge impact on the pharmaceutical manufacturing landscape in Ireland, and now its methods of production is gaining industry recognition also. he company employs ification for the production choice to be administered T 150 people at the Mulhuddart facility, of which about 60 work in “These successful of medical devices. Manufactured as early as possible in the treatment of osteoarthritis. Bromelain tablets, an anti- production. Currently the initiatives are Products inflammatory product, a plant produces 350 million The operation in west sustained release capsule sachets and over 450 mill- attributable to Dublin manufactures a formulation of Aspirin and ion capsules/tablets, which range of capsule, sachet the laxative Plantago Ovata is over four times the amount a growing and tablet formulations in sachets are also manufac- produced when the com- addition to the API Cryst- tured on site. pany set up in Ireland in team of alline Glucosamine Sulph- 1999. ate. The company’s leading Successful The plant obtained auth- dedicated, product DONA (the original Investment orisation to produce phar- Glucosamine Sulphate) is In 2009 Rottapharm ann- maceutical specialities of talented and manufactured in sachet ounced that it was under- the Irish Medicines Board flexible and capsule forms for mar- taking a €7 million invest- in January of the following kets in Europe, Asia and ment project. This was year. That same year, it personnel” South America. completed in 2010 and the obtained the ISO 9002 cert- DONA is the drug of first investment involved the Manufacturing Ireland Feb 2012 7
  • 2. Final MI Feb Main Doc 30/1/12 3:04 pm Page 9 Pharmaceuticals transfer of a number of new processes from anoth- er facility within the group. The project resulted in an additional four packaging lines, two coating systems and an encapsulation mach- ine. The volumes of finished product packaged doubled as a result and an addition- al 35 new jobs were creat- ed. Rottapharm now has five sachet lines, two blis- ter lines and two bottling lines in the packaging area. Factory costs have risen by only 12 per cent - with this increase in packaging vol- ume. Standing Alone Rottapharm are currently Rottapharm Certificate of Excellence winner for MEETA Maintenance and Asset Management processing 46,000kg of Awards 2011 Sachet line 6 TPM Project - Pictured (l-r) are Noel O’Regan, PMI; Ray Burtenshaw, material per week within Rottapharm; Bella Busko, Rottapharm; Aleksandra Wietrzyk, Rottapharm; Richard Hayes, their manufacturing areas Rottapharm; John Coleman, MEETA; Conor Campion, Rottapharm and Cormac Quaid, Rottapharm which encompasses API and bulk solid dosage inter- been completed. from each area of the fac- mediates. This represents “We have The plant dehumidifica- tory. The use of net presen- a 50 per cent increase on tion system was re-engin- ter on personnel comput- manufacturing volumes had great eered to supply dehumidi- ers and bulletin boards in since 2008. fied air to process equip- various locations on site Rottapharm Madaus dis- success with ment rather than to pro- ensures employees are covers, develops and com- cess rooms. As result there aware of the on-going mercialises a range of is now one dehumidifier energy projects. products for the treatment the Irish supplying four sachets of anti-inflammatory, anti- lines where previously Industry Recognition rheumatic, bone metabo- operation there was two dehumidi- “All companies like to lism, menopausal and gas- fiers supplying two sachet win awards and be recog- tro-intestinal disorders. To lines. Electricity usage in nised for projects that they date research activity has over the last 2011 was reduced by 20 per completed. It’s important generated about 300 pat- cent compared to 2010. for the team members to ents and 19 new drugs. 13 years and Planned projects for 2012 feel that they are part of a include the installation of growing and reputable Energy Efficiency we are very control software on two company that can compete In terms of operations chillers units along with a and win awards against Rottapharm is very dedi- site wide installation of LED stiff opposition.” cated to energy efficiency pleased with lighting. In addition, it is “We consistently look for and green energy cost cut- planned to use the heat new ways to reduce ener- ting programmes. Energy the initiatives generated from a Regen- gy costs, not just with gas efficiency projects became erative Thermal Oxidiser to and electricity but with a major part of Rotta- heat water in a heat water and waste saving pharm’s focus in recent undertaken in exchanger and pump the projects too. Recently a times in a drive to improve water back to the boiler project was initiated inv- cost competitiveness. In the pursuit of room to pre-heat the return olving the EPA Green the past few years major MPHW to the boilers. A Business Programme where projects on the HVAC sys- operational cross-departmental envi- we are looking at recycling tem, lighting arrangements, ronmental and energy team water from the effluent boilers and the building is in place, which helps tank where the process management system have excellence” gather energy saving ideas water is treated and also Manufacturing Ireland Feb 2012 9
  • 3. Final MI Feb Main Doc 30/1/12 3:04 pm Page 11 Pharmaceuticals ines a range of KPIs were formulated for perform- ance reviews. “We have seen a sub- stantial reduction in equip- ment failure rates plant wide since the system went live. The linking of Barco and PEMAC will also facilitate the introduction of meter based mainte- nance with actual running times determining routine maintenance requirements,” said Wesley Horan, Project A view of the Rottapharm facility in Mulhuddart, Dublin Manager CMMS. “The paperless mainte- the retentate from the puri- to support timely and accu- nance system compliments fied water loop. We will “We have rate information about the MES system installed in make a submission in res- seen a maintenance activities. The production and the ware- pect of the SEAI energy system was installed and house last year. We now awards next June. The obj- substantial validated to CFR 21 stan- have electronic batch ective is not to waste energy dards within six months records instead of paper - if we get recognition for reduction in with data access and input batch files on all of our our endeavours through via military standard lap- packaging lines and 90 per national awards that’s an equipment tops at the machines. cent of our manufacturing added bonus,” said Conor failure rates areas. The Werum MES Campion, Facilities Manager. Maintaining system, which took two Since the commencement plant wide Performance years to roll out plant wide, of manufacturing opera- This system enabled has delivered significant tions in 1999 the plant has since the maintenance activities to efficiency gains in produc- received many awards be logged as they happen. tion and quality assurance. including the Sustainable system went In conjunction with a Barco Paper has all but disap- Building Award, NISO Occ- OEE system which is uniq- peared within the engi- upational Safety Award, live” uely integrated into mach- neering and production Excellence Through People Gold Standard and now the MEETA awards. “We were delighted to win two awards for mainte- nance excellence at the annual MEETA awards run by Engineers Ireland last November. It was the first time we had entered for the awards. Our Paperless Maintenance project won first prize in the Mainten- ance Management category whilst we were awarded a Certificate of Excellence for our TPM project,” said Pat Garrahy, Managing Director. The Paperless mainte- nance project involved the installation of a comput- erised maintenance man- agement system called PEMAC from PMI Software An encapsulation machine in operation Manufacturing Ireland Feb 2012 11
  • 4. Final MI Feb Main Doc 30/1/12 3:04 pm Page 13 Pharmaceuticals The sustained engagement of our personnel with con- tinuous improvement is directly linked to business performance. The involve- ment of employees at all levels has brought about cost reductions, improved productivity and increased compliance. We have plac- ed great emphasis on employee empowerment, leadership behaviours and clear communication under- pinned by a common vision to drive all our CI activities”. Rottapharm Madaus is an Italian multinational group headquartered in Monza, Italy. It employs more than 2,000 people worldwide. It is active in about 85 countries world- wide and has manufactur- ing sites in Ireland, Italy, India, Germany and Spain. Looking to A sachet line in operation in the new facility the Future The company aims to environment because of lines in the plant with OEE grow its contract manufac- the MES and CMMS pro- “All averaging 68 per cent. turing business for sachets jects,” said Paul Ludorf, companies The project created a in the coming years. Comp- Technical Manager. sense of equipment owner- letion of a new process like to win ship between production development laboratory Performance and maintenance person- later this year will support Standards awards nel by working together to this aspect of the Rotta- The strategy for operat- establish the correct pro- pharm Ireland business. ional excellence was rolled and be cesses and practices. We Rottapharm aims to inno- out when the new 2,000 sq recognised have now incorporated vate continuously, combin- metre facility was opened TPM into our continuous ing CI programmes with a for production and since for projects improvement programme. strong technology platform, then, the processes put in This year we plan to have to position the company for place by management, and that they 70 per cent of all employ- future growth. adhered and added to by ees participating in CI “We have had great suc- staff, has garnered the completed. It’s teams rising to 100 per cent cess with the Irish opera- praise of Rottapharm’s peers. important for in 2013,” said Richard tion over the last 13 years “Our TPM project was Hayes, Continuous Improve- and we are very pleased initiated in July 2010 on a the team ment Manager. with the initiatives under- fully automated sachet fill- taken in the pursuit of oper- ing and packaging line. The members to United Team ational excellence. It is project team of production Pat Garrahy explained, planned to replicate the and maintenance personnel feel that they “These successful initia- continuous improvement followed a nine-step imp- are part of a tives are attributable to a model deployed in Dublin to rovement plan, which inv- growing team of dedicated, other production plants olved significant capital growing and talented and flexible per- within the Rottapharm investment in refurbish- sonnel who have demon- Madaus Group,” Dr Enzo ment. At the end of the pro- reputable strated great commitment Lacchini, Corporate Tech- ject the line was one of the to working together for nical Director, Rottapharm best performing packaging company” improved site performance. Madaus. Manufacturing Ireland Feb 2012 13