Angelo Alletto is a pro­duc­tion engi­neer at Roche Diag­nos­tics in Mannheim and his mis­sion is clear: “His” line number 13 must be run­ning in order to reach the required pro­duc­tion output at the end of each week. In other words: 85 cycles per minute, 16 hours a day and ide­ally without inter­rup­tions. “The machine should only stop when we have planned it, not because some­thing has broken,” says Alletto.

With the intro­duc­tion of a Pre­ven­tive Main­te­nance Plan this year, Roche and Harro Höfliger have set out on a shared path to achieve pre­cisely this goal. Roche‘s Elecsys^®-Tech­nology has been on the market for about 20 years. Lab­o­ra­to­ries all over the world use it in many areas of immunology. The suc­cessful diag­nostic product con­sists of up to three com­po­nents in sep­a­rate plastic bot­tles, which Roche com­bines, labels and pack­ages in dif­ferent ways with Line 13. It is also con­stantly con­trolled by numerous cam­eras, sen­sors and check­weighers to make sure that only per­fectly pro­duced and there­fore 100% safe prod­ucts leave the plant.

“The many com­bi­na­tions and carton for­mats, as well as var­ious pack­aging inserts with their tol­er­ances, make the pack­aging process prone to errors,” says Alletto and adds: “Together with Harro Höfliger‘s Cus­tomer Ser­vice we have been able to opti­mize many fac­tors in recent years and in doing so have con­tin­u­ously increased our output.”

14 machines work closely together

Line 13 con­sists of var­ious machine types and includes tray­loaders, an assembly unit, sev­eral labelers, carton erec­tors and a toploader car­toning machine. In addi­tion, the line has numerous feeding and con­trol sys­tems – a com­plex array of 14 machines that work together in closely timed inter­vals. Main­taining the entire system in such a way that tech­nical mal­func­tions can be avoided is what the Pre­ven­tive Main­te­nance Plan shall make pos­sible in the future.

“We will no longer use our budget for unsched­uled repairs between main­te­nance inter­vals, but for pre­ven­tive and care­fully pre­pared main­te­nance activ­i­ties. This enables us to achieve a more stable pro­duc­tion process that gives us the time and flex­i­bility to iden­tify and imple­ment fur­ther opti­miza­tion needs,” explains the pro­duc­tion engineer.

But there is another reason for plan­ning main­te­nance more pre­cisely, Alletto knows: “Inspec­tion author­i­ties such as the FDA or even the TÜV (German Tech­nical Inspec­tion Authority) nowa­days demand doc­u­men­ta­tion that is more pre­cise and goes far beyond the time of the actual approval. Ticking off main­te­nance check­lists is no longer suf­fi­cient.” Thanks to the main­te­nance plan and the asso­ci­ated doc­u­men­ta­tion, from now on Roche will be able to pro­vide trans­parent evi­dence as to which checks and main­te­nance activ­i­ties were car­ried out and when they took place.

Main­te­nance needs preparation

In order to imple­ment the Pre­ven­tive Main­te­nance Plan, some ini­tial prepa­ra­tion is required. In addi­tion to the expe­ri­ence from pre­vious main­te­nance work and daily oper­a­tion, an eval­u­a­tion of the machine serves as a basis. “To this end, all machine com­po­nents are ana­lyzed by our tech­nical experts and rated with regards to expected wear and tear, the prob­a­bility of failure and the resulting effects,” explains Sven Fis­cher, Ser­vice Man­ager at Harro Höfliger. Fis­cher has been respon­sible for Roche for many years and has played a key role in advancing the Pre­ven­tive Main­te­nance Plan project.

“We main­tain an open and honest com­mu­ni­ca­tion with our cus­tomers. Roche‘s sys­tems receive our utmost atten­tion. As a result, we were able to develop indi­vidual solu­tions together with Roche which made it pos­sible to con­tin­u­ally increase pro­duc­tion effi­ciency. We con­sider the Pre­ven­tive Main­te­nance Plan a large sign of con­fi­dence and the result of our excel­lent team­work,” says Sven Fis­cher. A coop­er­a­tion that will become even stronger. “Pre­ven­tive main­te­nance is an ongoing process,” explains Angelo Alletto. “Main­te­nance plans are living doc­u­ments that we will con­tin­u­ally refine and adapt. Together with Harro Höfliger, we are get­ting better and better and can con­tinue to increase our production.”

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Photos: Roche Diagnostics