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Passing the Audit Risk-Based Process Verification with Good Weighing PracticeTM
For over 200 years, the German-based company Klosterfrau Healthcare Group has been developing, manufacturing and selling pharmaceutical products. Its portfolio combines traditional remedies with modern drug therapies and encompasses more than 30 brands and nearly 220 over- the-counter products.
At its Berlin site, the company runs state-of-the-art production lines. Scales and balances, whether in quality control or production, are an integral part of the process. Every piece of weighing equipment in use must be regularly calibrated and qualified to ensure regulatory compliance.
The challenge for Claudia Brostmeyer, Head of Quality Control at the Berlin site, is to ensure that all workplaces with their variety of processes and responsibilities calibrate and qualify weighing equipment according to stringent Good Manufacturing Practice and Good Laboratory Practice standards.
Running a compliant weighing station is more complex than it may seem. In addition to making sure that a scale or balance is suitable for the application, sound documentation must prove that suitability to auditors. Operators also must be trained according to valid standard operating procedures to ensure periodic equipment testing, calibration and qualification is done accurately.
When Brostmeyer learned about Good Weighing Practice™ (GWP® ) Verification from Mettler Toledo, she immediately recognised that this
approach would make her life easier. “GWP is a well thought-out and accepted concept that provides a scientific basis for our weighing equipment verification needs,” she said.
After Mettler Toledo conducted a GWP Verification assessment at Klosterfrau’s Berlin site, Brostmeyer received a risk-based assessment and testing recommendations for each scale and balance.
“What I like about the verification document is that it clearly states whether the equipment is suitable for the given process. It also provides recommendations on which tests should be conducted at which intervals with which test weights,” said Brostmeyer. “That makes it easy for me to instruct operators and maintenance personnel on appropriate testing procedures.”
Shortly after Mettler Toledo verified the weighing equipment, a production audit put the new process to the test, leaving no questions unanswered.
To learn more about how GWP and GWP Verification can establish weighing rationale and help your organisation pass its next audit, go to
www.mt.com.
42840pr@reply-direct.com
New System Provides Accurate and Safe Bottle-top Dispensing of Many Common Laboratory Liquids
Gilson, an industry leader in liquid handling, purification, and extraction systems, have introduced DISPENSMAN™, a bottle-top dispenser for convenient, safe, and precise delivery of common laboratory solutions and solvents. DISPENSMAN continues the innovation of Gilson’s liquid handling line, which also includes PIPETMAN® volume pipette.
, the first continuously adjustable-
DISPENSMAN has an innovative, three-position nozzle that controls the dispensing of liquids, the removal of air in the system to avoid liquid loss, and includes an anti-drip safety feature that returns liquid to the bottle. Make volume changes quickly and easily by pushing to unlock and then sliding the volume adjuster to the desired dispensing volume with no need to open bottles, decreasing chances of contamination.
DISPENSMAN is easily calibrated by the user and accommodates most liquids including many acids, bases, and solvents. The system is autoclavable, and does not require consumables such as tips.
Five DISPENSMAN models are available that cover various volume ranges from as low as 0.25 mL up to 50 mL. All meet ISO 8655 specifications. A variety of adaptors are also available that allow the DISPENSMAN to be used with most common bottle types.
For more information on DISPENSMAN bottle-top dispenser, please visit
www.gilson.com/dispensman 42972pr@reply-direct.com
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