Platinum Press, Inc. (PPI), a provider of healthcare packaging solutions specializing in labels, folding cartons, blister packaging, inserts/outserts and medication guides, has recently become a fully certified print packaging supplier for all Walgreens pharmacies.
 
To earn the quality assurance certification, PPI underwent a stringent program administered by Graphic Measures International (GMI), an organization that monitors and validates required process controls for its vendors. This certification enables PPI to gain full approval as a print packaging supplier for Walgreen Co., which operates approximately 8,200 pharmacies nationwide.
 
Additionally, the company is expanding with a new manufacturing facility in Pine Brook, NJ, providing packaging components for production plants in the NY/NJ area, and is expected to create 40 new jobs. The new space supplements the company’s Grand Prairie, TX headquarters and will serve to reduce shipping costs and weather issues for its Northeastern customers.
 
Chris Hicks, vice president of Quality for PPI discusses the Walgreens supplier audit, in-process production controls, QA/QC processes and equipment, as well as expansion plans for the company’s new Pine Brook facility. – Kristin Brooks

Contract Pharma: What role did PPI’s QA/QC process play in becoming a supplier for Walgreens Pharmacies? 
    
Chris Hicks: Quality was instrumental in the overall auditing process. Facilitating the audits, in particular, the follow-up audit assured that the information required to achieve certification was appropriately presented in an efficient and effective manner. Streamlining the audit process and presentation of the information is a critical component in the overall outcome of the audit process and ultimately proved successful. However, it must be duly noted that the GMI certification achievement was inspired and only successful because of the diligence and hard work from the entire team at PPI. 
 
CP: What type of equipment does Platinum Press use for inspection and QA/QC purposes? Is inspection performed inline, offline, a combination of both? 
 
CH: Platinum Press utilizes numerous quality control tools throughout the labeling production process from artwork design to finished product release. The controls are in place to assure that finished products meet predetermined specifications and quality attributes.
 
Artwork design is conducted in house and proofed using fully automated and validated electronic document and artwork comparison software. The software compares a sample electronic file (i.e. label or insert) against a standard master electronic file to assure that all information is correct in the sample file. The software identifies deletions, insertions, changed text, font changes, location, spelling differences and artwork variations. The Quality Assurance department completes the proofing and generates a difference report that is forwarded to Graphics for review and correction as necessary prior to sending to the client for initial review and all revisions thereafter.

In-Process Production Controls:

• In-process controls during Lithographic production are numerous. Production orders complete with approved client proofs, product specifications, process instructions and Job Tickets with critical sign off areas are utilized. Support technology includes:

• Fully automated systems that compare a production sample (printed sheet) to the client approved electronic proof (master file). The sample file is generated using a printed press sheet and scanned using a high resolution scanner. The scanned image is then compared to the master file. Difference reports are generated and included in the production record as part of order history. This test is performed at the beginning of the run and at the end of each production order printed.

• In-process checks are performed using 12 quality attributes every 250-500 sheets throughout a production run. These checks are performed by press operators and Quality personnel, documented on in-process forms and retained with the Order Files as part of order history.

• Barcode verifiers are used to ensure all printed barcodes meet client specified ANSI grades where applicable.

• Spectrodensitometers and spectrophotometers are used as necessary for consistent color matching.

• In-process controls during Flexographic production are also numerous. Production orders complete with approved client proofs, product specifications, process instructions and Job Tickets with critical sign off areas are used.

• Video Web Inspection Systems units view the web in real time as the machine is running and displays the images on a monitor. The systems allow the operator to effectively identify, flag and correct print quality issues while printing real time.

• In-process testing of each roll is also performed with up to 16 quality attribute checkpoints.

• Spectrophotometers are used as necessary for consistent color matching.

• Barcode verifier is used to ensure all printed barcodes meet client specified ANSI grades.

• In-process controls for Finishing and Inspection:

• Verification Inspection System units are used after the Flexographic printing process to conduct high speed 100% vision inspection of the master label rolls. The inspection units are fully integrated with the rewind machines and stop the machines upon detection of a suspect defect. The suspect defect is displayed on a monitor and operator interaction is then required to verify/correct the issue and resume inspection. These units have the capability of finding errors of missing or additional print as small as 0.016” x 0.016”.

• For sequential numbering of labels, front or backside Verification Inspection Systems are utilized for high speed inspection of the coding process. The systems inspect all codes printed on the liner or labels and stops the numbering machine when a suspect defect is detected, requiring the operator to verify/correct the issue and resume inspection.

CP: Have any of PPI’s QA/QC processes “gone digital”? Any new, equipment being utilized?
   
CH: Yes, the utilization of electronic artwork and proofing software promote increased throughput while capitalizing on precision. Both artwork and text documents can be 100% reviewed in a matter of minutes with extreme accuracy. This correlates to rapid turnaround times for artwork and increased customer confidence in the artwork proofing process.
 
CP: Increasingly, brand owners want tighter controls over their brand colors across multiple packaging platforms. What tools does Platinum Press use for color quality control?  
 
CH: Spectrophotometers are utilized to assure color consistency from run to run from an in-process quality control perspective. However, high quality print plates are critical in ensuring high print quality including color. For this reason, PPI utilizes digital plate imagers and start of the art software to produce high precision print plates.
 
CP: What do you see as the most challenging aspects of your role as VP of Quality? 
    
CH: The most challenging aspect related my role is the overall growth management from a global perspective. The influx of new equipment, printing and inspection technology and most importantly, the human elements presents extreme multi-tasking challenges. However, I am fortunate to have a very intelligent, hardworking and dedicated support staff to assure the transition into a new era for PPI is attainable and successful.
 
CP: What plans are being made from a QA/QC perspective for PPI’s expansion into NJ? Will the QA/QC systems mimic the Texas facility?
    
CH: Yes. The QA/QC systems deployed at the NJ facility will be a carbon copy of the systems used in Texas. In fact, all key personnel manning the NJ facility will spend several weeks at the Texas plant training on equipment, systems and procedures already in place and to be used in the new facility. This will ensure a mirror image of systems and processes that have a proven track record for quality at PPI.

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Kristin Brooks has been associate editor at Contract Pharma since 2004.