New Packaging Technology Gears Up for GMPs

April 27, 2009

Adhering to strict good manufacturing practices (GMPs) for tablets and capsules is a challenge for nutraceutical companies both large and small-and soon, smaller companies may face this challenge as well. As an example of strict GMP guidlines, GMP advises: "Process controls for dietary supplement manufacturers include establishing and meeting specifications to ensure the finished dietary supplement contains the correct ingredient, purity, strength, and composition."

Adhering to strict good manufacturing practices (GMPs) for tablets and capsules is a challenge for nutraceutical companies both large and small-and soon, smaller companies may face this challenge as well. As an example of strict GMP guidlines, GMP advises: "Process controls for dietary supplement manufacturers include establishing and meeting specifications to ensure the finished dietary supplement contains the correct ingredient, purity, strength, and composition."

Small wonder that the newest technological advances are concerned with meeting the GMPs. Tablet and capsule quality means accurate inspection. In March 2009, Symetix (Walla Walla, WA), the pharmaceutical and nutraceutical arm of Key Technologies, introduced the VeriSym/N compact high-volume optical inspection system capable of checking 1 million nutraceutical softgels or tablets per hour.

The system automatically verifies product color, size, and shape and removes defects and foreign capsules and tablets (unconfirmed objects) from the product stream along with broken, stained, or partially coated tablets; softgels with air bubbles; stained capsules; and misshapen product.

Historically, most nutraceutical manufacturers and contract packers have relied on slow-moving automatic systems or subjective and inconsistent manual inspection. Compared with these methods, VeriSym offers a payback as rapid as one year based on labor savings alone. Improvements in production efficiency and product yield further speed payback.

HIGH-SPEED INSPECTION

IN A SIMILAR VEIN, the Elizabeth Companies (Louisville, KY) verifies tablet quality with two versions of its Viswill tablet-inspection systems. The high-speed TVIS-EX3 system operates at speeds up to 350,000 tablets per hour and accuracy down to 50 µm. This system can inspect up to 130,000 tablets per hour and has a 100-µm inspection capability.

Robinson Pharma Inc. (RPI; Santa Ana, CA) announced that it successfully completed a surveillance audit for CGMP-compliant manufacture of dietary supplements. The audit was performed by a leading global third-party testing and auditing firm focused on quality systems and analysis.

The quality systems audit analyzed the RPI standard operation procedures (SOPs), staff qualifications, staff training program, and facility adequacy and cleanliness. All aspects of the manufacturing process were reviewed, including receipt and authentication of ingredients, the production process, postproduction product analysis, product handling, and record- keeping.

RPI, which holds a drug manufacturing license issued by the state of California, was shown to comply with the quality standards required to ensure safety, purity, and label claim compliance for dietary supplements marketed in a leading national retail chain.

The small size is an added benefit. The system's footprint is a mere 38 × 120 in., including the vibratory product feeder. Quick turnover is another plus.

Product settings can be stored in memory for quick and easy recall via the icon-based graphical user interface. Proprietary color cameras are the key. Four primary inspection cameras are located above and below the product stream. The system can be programmed to send an alarm or stop the product flow when an unconfirmed object is detected, which prevents unconfirmed objects from being accepted.