Pharmacode Data Check for Medication Packaging

Phar­ma­ceu­ti­cal pack­ag­ing is a sophis­ti­cat­ed and mul­ti-staged process that involves machines and humans dili­gent­ly work­ing side by side. The pack­ag­ing process con­sists of more than 20 steps, and each is very complex.

Crit­i­cal steps include:

• phys­i­cal­ly sep­a­rat­ing prod­ucts to avoid mix­ing-up fin­ished and unfin­ished items.
• mul­ti­ple checks to ensure that med­i­cines con­form to the descrip­tions giv­en in the product’s batch man­u­fac­tur­ing record (BMR).
• iden­ti­fi­ca­tion of pack­ag­ing that con­tains rel­e­vant med­ical instructions.
• elim­i­nat­ing excess materials.
• ran­dom test­ing and much more.

How­ev­er, phar­ma­ceu­ti­cal fac­to­ries are fre­net­ic. Work­loads can be over­whelm­ing because mul­ti­ple pro­duc­tion lines simul­ta­ne­ous­ly churn, pro­duc­ing or pack­ag­ing any­where from 10–100 dif­fer­ent med­ica­tions. The environment’s fren­zied nature also can trig­ger human error at any stage. Exter­nal fac­tors, such as labor short­ages, can also hin­der med­ica­tion packaging.

There­fore, fac­to­ries must take extra steps when mis­take-proof­ing pack­ag­ing lines. After all, pro­tect­ing prod­uct safe­ty and a company’s rep­u­ta­tion (along with rev­enue) can­not be under­em­pha­sized because human lives are lit­er­al­ly on the line. For instance, in 2013, French author­i­ties dis­cov­ered that zopi­clone (a sleep­ing pill for insom­ni­acs) was dis­cov­ered in pack­ages of furosemide diuret­ics. Police inves­ti­gat­ed deaths pos­si­bly linked to the improp­er­ly pack­aged med­ica­tion, and a large-scale recall was issued.

Giv­en the con­se­quences of improp­er­ly labeled or pack­aged med­ica­tion, Job #1 is ensur­ing that the cor­rect med­i­cine and asso­ci­at­ed instruc­tions are placed in the cor­re­spond­ing pack­ag­ing. Doing so cor­rect­ly ensures drug pack­ag­ing com­pli­ance, and it’s pre­cise­ly where Germany’s Elmi­cron GmbH steps in to help.

ISO: In Search Of Quality

Elmicron’s spe­cial­ty lies in bar­codes, data matrix codes, and RFID tech­nol­o­gy for label­ing and identification.

“We are the pio­neers who helped devel­op bar­code tech­nol­o­gy and stan­dard­ize it with­in Europe’s cer­ti­fi­ca­tion soci­eties,” beams Dr. Har­ald Oehlmann, Elmicron’s man­ag­ing director.

Fur­ther­more, thanks to exten­sive prac­ti­cal expe­ri­ence and a team of high-pro­file experts, Elmi­cron has imple­ment­ed cross-indus­try and val­ue-added con­cepts for sev­er­al of Europe’s top busi­ness­es. Giv­en Elmicron’s mis­sion to help cus­tomers ensure accu­ra­cy via automa­tis­che datenkom­mu­nika­tion (auto­mat­ic data com­mu­ni­ca­tion), it is fit­ting that the com­pa­ny worked to earn an ISO 9001 qual­i­ty man­age­ment certification.

Car­ry­ing ISO 9001 demon­strates Elmicron’s com­mit­ment to pro­vid­ing high-qual­i­ty prod­ucts that meet both cus­tomer qual­i­ty and reg­u­la­to­ry require­ments while val­i­dat­ing Elmicron’s sys­tem for use by inte­gra­tors and at the customer’s site. Last­ly, the ISO 9001 cer­ti­fi­ca­tion ver­i­fies that Elmicron’s experts under­stand the intri­ca­cies of qual­i­ty man­age­ment sys­tems and cor­po­rate governance—exactly what phar­ma­ceu­ti­cal firms need to main­tain prod­uct qual­i­ty and their good standings.

The Dr. Pre­scribes the Phar­ma­code Data Check Inspec­tion System 

The phar­ma­ceu­ti­cal industry’s pack­ag­ing plights caught Dr. Oehlmann’s atten­tion, inspir­ing him and his team to devel­op Elmicron’s Phar­ma­code Data Check inspec­tion sys­tem. The sys­tem con­sists of pro­pri­etary Elmi­cron soft­ware run­ning on an indus­tri­al-grade Noax touch­screen com­put­er. Data cap­ture occurs with Code Corporation’s CR5000 Bar­code Read­er to read PHARMA-CODE—a high­ly spe­cial­ized, and often col­or-keyed, bar­code type used in phar­ma­ceu­ti­cal packaging.

A trade­mark of Lae­tus, PHARMA-CODE pre­vents the inter­mix­ing of med­ica­tion pack­ag­ing. A spe­cif­ic PHARMA-CODE cor­re­lates to a spe­cif­ic med­ica­tion, such as an antibi­ot­ic. This code is then assigned to every part of the medication’s pack­ag­ing (for exam­ple instruc­tions, labels, blis­ter packs, and con­traindi­ca­tion info). IT sys­tems man­u­fac­tur­ers, such as Elmi­cron, then cre­ate val­i­da­tion solutions.

With a firm­ly cement­ed foun­da­tion thanks to their bar­code stan­dard­iza­tion work, a chance tech­ni­cal sup­port request unit­ed Elmi­cron and Code.

“In the ear­ly 2000s, Elmi­cron [via US-based Omni­tron Sys­tems, a net­work con­nec­tiv­i­ty spe­cial­ist] received the task for tech­ni­cal sup­port in Europe from an over­seas client,” recalls Dr. Oehlmann.

The sup­port con­tract was linked to Code Corp., and after their ini­tial project, a part­ner­ship solidified.

“We have been work­ing with Code for decades, and they’ve con­sis­tent­ly proven their reli­a­bil­i­ty in terms of high qual­i­ty and good ser­vice,” reflects Dr. Oehlmann. “Our joint work has devel­oped into a suc­cess­ful, long-term part­ner­ship. So when the need for Phar­ma­code Data Check arose, Code’s CR5000 was our first choice since we trust Code prod­ucts. They pro­vid­ed us with a suit­able device for our project.”

As Dr. Oehlmann rec­ol­lects, ear­ly dur­ing devel­op­ment, Elmicron’s team man­dat­ed that the CR5000 must pro­vide rapid bar­code scan­ning. Addi­tion­al­ly, the scan­ner had to read the same bar­code mul­ti­ple times with a brief break between scans, all while sup­port­ing hands-free work­flows. Code reps demon­strat­ed that the CR5000 met Elmicron’s needs dur­ing prod­uct eval­u­a­tion, attract­ing the atten­tion of developers.

Inte­gra­tion began, and the firm rela­beled the CR5000 as Elmi­cron Mod­el ECR 5210 lin­ear & 2D, “Phar­ma­code Data Check con­fig­u­ra­tion.” Beyond their essen­tial require­ments, the devel­op­ers dis­cov­ered addi­tion­al CR5000 fea­tures and func­tions that would give Elmicron’s sys­tem addi­tion­al flex­i­bil­i­ty. For instance, the bar­code read­er pro­vides Phar­ma­code Data Check sup­port and pre­sen­ta­tion mode, as well as man­u­al and auto­mat­ic scanning.

Dr. Oehlmann also added that the bar­code reader’s USB-POS scan­ner inter­face is high­ly advan­ta­geous because no Win­dows dri­ver is need­ed, and it has a bina­ry inter­face. More­over, via USB-POS, CR5000 offers a bidi­rec­tion­al inter­face to the NOAX touch­screen for dis­play­ing “OK” or “wrong data” for the cur­rent scan. Anoth­er par­tic­u­lar­ly unique fea­ture, he notes, is that the CR5000 is JavaScript-based and will run vir­tu­al­ly any soft­ware users need. Near­ly all of Code’s bar­code read­ers are built on JavaScript, enabling them to offer data pars­ing and oth­er functionalities.

The savvy inte­gra­tion of indus­tri­al- and enter­prise-grade com­po­nents has giv­en the Phar­ma­code Data Check inspec­tion sys­tem a fair degree of cus­tomiza­tion. Thus, Elmi­cron has mod­i­fied the sys­tem for deploy­ment in auto­mo­tive pro­duc­tion, elec­tron­ics, tobac­co, con­sumer pack­aged goods, and the marine sec­tor, among others.

The Chal­lenge: Prob­lems Per­fect­ly Pack­ing Pills

Giv­en the impor­tance of the system’s mis­sion, flaw­less per­for­mance was a must. How­ev­er, Code and Elmi­cron faced two chal­lenges dur­ing sys­tem development:

1. The Phar­ma­code Data Check device would unex­pect­ed­ly reboot, stop­ping bar­code scan­ning, which neces­si­tat­ed trou­bleshoot­ing because a missed scan dur­ing pack­ag­ing would lead to mis­takes. Code’s tech sup­port team had this sort­ed out with­in four weeks.
2. Quick re-scan pre­ven­tion of the same code had to be dis­abled by con­fig­u­ra­tion codes.

“We would advise any­one who requires a bar­code scan­ner solu­tion, both hard­ware or soft­ware, to use the full capa­bil­i­ty of Code’s solu­tions,” encour­ages Dr. Oehlmann.

The Results: Grow­ing Demand for Qual­i­ty Assurance

Elmicron’s Phar­ma­code Data Check Inspec­tion Sys­tem is enjoy­ing demand across Europe because it hits the goals of:

• Qual­i­ty assur­ance through error detec­tion and avoidance.
• Sim­ple operation.
• Inte­grat­ed func­tion­al­i­ty and automation.

More­over, Elmicron’s cus­tomers can guar­an­tee 100 per­cent con­trol of the med­ical pack­ag­ing process, giv­ing them a deci­sive advan­tage over com­pet­ing firms.