Almac, a leading, global service provider to more than 600 pharmaceutical and biotechnology companies worldwide, offers a broad range of packaging services that include r&d, biomarker discovery and development, api manufacture, formulation development, clinical trial supply and its own, proprietary and integrated phoneandinternetbased patient response and drug management system. The company, with 3,000 employees, is based in craigavon, northern ireland, and is joined by uk facilities in elvingston and manchester and u.s., facilities in durham, nc, san francisco, ca, and two sites in pennsylvania souderton, site of the recentlyopened, 120 million, 240,000 sq.
Ft. North american headquarters site and audubon, pa, the company&rsquos u.s. Commercial pharma copacking flagship. While almac has operated the 100,000sq.ft. Plant as a contract packaging facility since 1997, it&rsquos been strictly dedicated to clinical products, or precommercialized products, such as those used in clinical trials. All that began to change in the fall of 2011. &ldquoaudubon has always been a packaging facility, but now it&rsquos a commercial packaging facility,&rdquo says david downey, vice president of business development for almac pharma services &ldquo100 of the business resources, employees and investments at the upgraded plant will be dedicated to providing contract commercial packaging services.&rdquo the initial 10million capital outlay for the clinicaltocommercial packaging conversion at audubon was just a start. The company spent millions more on high speed equipment for blistering, bottling, walleting and biopharmaceutical labelingpackaging.
The company&rsquos longterm compliance to mandates from the u.k.&rsquos mhra, or medicines and healthcare products regulatory agency, give lead the company to expect a glitchfree u.s. Food and drug agency validation and approval process. A peek inside the plant upon fda approval, likely this fall, audubon will host commercial primary and secondary packaging of branded prescription and overthecounter otc drug packages. These include tablets and capsules into bottles, blisters, wallets and hospital unit dose formats along with secondary labeling and packaging of biopharmaceutical vials and ampoules. Automation and integration are keys to productivity and throughput, from major assets to the controllers, servos, touchscreens, oee routines and in some cases, touchscreen interfaces that improve life on the line for operators.
These technologies support several new packaging machines. Some highlights a new highspeed blister line for primary packaging of solid oral dose products in materials including pvc, pvcpvdc, aclar and aluminum. This 3.3million highspeed uhlmann ups 4 system with integrated c2206 cartoner is rated to package up to 12,000 blisters per hour with online digital or flexo printing. Quality control software manages integrated checkweighing, printing and visionbased autorejection. A high speed bulkfill bottling line for dispensing tablets into bottles, jars and tubs at speeds up to 14,400 bottles per hour.
Electronic filling systems with inline fill sensors will confirm fill count accuracy, complete with labeling and component code and print verification. A newman 4val labeling system to apply clear and paper selfadhesive labels to more than 12,000 vials and containers per hour. Optical character verification inspects for bar codes on each label &ndash it can verify that the correct labels are on the container and reject mislabeled or nonlabeled containers. Ready for serialization pharma copackers are keenly aware of the increasing problems posed by counterfeiting, misbrandingpackaging and related illegal activities across the global pharmaceutical supply chain.
Further, global requirements are increasing for drugmakers and marketers to provide itemlevel serialization down to the smallest sellable, packaged unit. Accordingly in the united states, it appears that california&rsquos epedigree serialization initiatives will take effective starting in january 2015, with further nationwide adoption a possibility. Almac has customdeveloped its own serialization and 2d matrix barcoding system to meet the need for global gs1 serialization standards compliance. &ldquowe built and own and amend the software ourselves because we could not find a system on the market that met our requirements,&rdquo says geoff sloan., vice president of manufacturing operations for almac pharma services, adding &ldquoas a global company, we have no choice but to get ahead of the curve on this issue.&rdquo the system lets almac apply and verify 2d matrix barcodes to each individual package for traceability from manufacturing to the consumer enduse point.
Because serialization requirements aren&rsquot fully developed, and vary from country to country, the company implements different solutions as needed. For example, serialization data is applied to drug products entering turkey, where full itemlevel serialization is required, while 2d matrix barcodes are used for shipments to france and austria.
