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Pharmaceutical Package Integrity: Inspect 100% of Package Seals

by Gerbig in General Cleanroom. Comments Off on Pharmaceutical Package Integrity: Inspect 100% of Package Seals

Thermal imaging technology will shape the pharmaceutical industry to make package inspection thorough and precise.

Quality control standards in the pharmaceutical industry are predictably strict. Cleanroom protocols are not enough to guarantee that package seals are intact. Currently, a sampling method is used to determine package integrity. However, this is not an efficient method of quality control. The good news is that there is a far superior method on the horizon.

Dynamic thermal imaging technology has been available for some time, but it hasn’t been cost effective. Now, however, companies like Pfizer are conducting trial runs on imaging methods that, from a cost standpoint, could make thermal imaging commercially available.

Thermal imaging will deliver real-time testing of 100% of products in a line. This method doesn’t slow processes, compromise product, or interfere with production. It is a non-invasive, thorough, and portable.  The thermal … Read More »

Coach your Cleanroom Employees to be Indispensable

by Gerbig in General Cleanroom. Comments Off on Coach your Cleanroom Employees to be Indispensable

Cultivating your cleanroom employees to be indispensable is an investment in both the present and the future of your business

The happiest, hardest-working employees are those that feel cared for and supported. One of the best ways to deliver these principles is to train employees. Training isn’t just about skills, though. If your employees want to feel both valued and like they have a future with you, training should also include guidance on how to move up in the company. Here are some things to teach your employees:

Self-confidence. The first step in achieving a status of being irreplaceable is to believe that it’s true. This isn’t about blind arrogance. This is about feeling one’s full worth. Have employees evaluate their skills and what they think they need to feel like they are indispensable. This will provide a personal development track that … Read More »

Pharmaceutical Manufacturing Solutions: Microbial Detection in Water

by Gerbig in General Cleanroom. Comments Off on Pharmaceutical Manufacturing Solutions: Microbial Detection in Water

Guidelines for an online water bioburden analyzer may soon lead to a more reliable and sophisticated method of water quality assessment.

Risk reduction and process control in the pharmaceutical industry are in desperate need of modern technologies. This couldn’t be truer when it comes to water quality assessment. The traditional method leaves a lot to be desired. Thanks to an industry workgroup, a solution may be on the way.

The currently accepted practice for microbial detection in water is collecting samples at points-of-use (POU) and assessment via culture-based methods. The idea of POU testing is to reflect the quality of the entire water system. However, this provides limited sampling frequency and retrospective analysis (culture-based methods). Additionally, it is possible that a sample is contaminated during collection. Growth-based methods used here do provide the ability to identify organisms, however, many still go undetected.

The … Read More »

Sealing Leaks in the Cleanroom

by Gerbig in General Cleanroom. Comments Off on Sealing Leaks in the Cleanroom

Improper seals in cleanrooms can devastate the integrity of its environment and production therein. Here is one solution to this problem.

Cable management is essential to the integrity of a cleanroom, though it is often overlooked in the design process. Without proper seals, air leaks can contaminate the environment. Any sealing solution must be:

Designed, tested, and certified for long-term functioning
Approved for use in hazardous/potentially explosive environments
Able to seal all services within negative and positive testing regimes under high levels of pressure
Designed to be resistant to spikes, pressure and temperature fluctuations, and maintain positive or negative pressure, depending on the room
Able to maintain air-tightness

A proven solution to sealing issues is the compact sealing system. It creates airtight seals with minimal alterations to structure. It operates under constant pressure. Those compact systems that are certified will effectively seal services even under the most … Read More »