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 imaging units can swiftly be wheeled from one packaging line to another in a matter of minutes. The best news is it is also extremely precise.

By inspecting product seals with thermal imaging, temperature changes as slight as 0.02 degrees Celsius are detected. This ensures that any breaks in the seals are caught and corrected.

The capabilities are very diverse, which means that thermal imaging offers verification of a number of types of packaging as well as fill levels. These include:

  • Plastic bottles
  • Sachets
  • Pouches
  • Stick packs
  • Blisters
  • Other flexible packaging
  • Tablet fill inspection
  • Liquid fill inspection
  • Desiccant count/inspection

This powerful technology will assist the pharmaceutical industry in cleanroom, production, and output control. The end result will yield safer products for consumers and higher profits for manufacturers.

If you have questions about cleanroom construction, verification, or certification, we are here to help you. Gerbig Engineering Company has provided expert cleanroom solutions for 30 years. We manufacture AireCell cleanrooms as well as provide verification and certification. Contact us at 888-628-0056 or info@gerbig.com.

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:

  1. 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 will benefit both the employee and the company.
  2. Be aware of everything around you. This is a vague tip, but an important one. Employees should be on the lookout for opportunities to improve systems, catch areas in need, and lend a helping hand. Also, employees should have political savvy, especially in a sense to be able to explore alternatives.
  3. Cultivate creativity. Most tasks in a cleanroom are very left-brained – analytical and objective. By engaging in creative activities on breaks in and in one’s free time, anyone can foster the creativity that leads to innovation and groundbreaking change.
  4. Take care of the whole self. Work should be broken up with brief periods of exercise, stretching, breaks for the brain, and noticing one’s surroundings. Stress relief and basic muscle care can offer a lot of physical and mental relief – without which people become fatigued, stuck and overwhelmed.
  5. Be a team player. Helping others not only helps productivity, it strengthens skillsets. It shows leadership and builds respect – both from and for other employees.

All of these activities and tips empower employees to be an integral part of the team for years to come. Not only does this kind of training set people on a personal track, it also leads to higher productivity and success rates in compliance. If you have questions about cleanroom validation, certification, or construction, contact Gerbig Engineering Company. Our experts are happy to assist you in any phase of cleanroom operations. Call us at 88-628-0056 or email info@gerbig.com.

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 potential solution to this problem may surface thanks to a workgroup of representatives from seven major pharmaceutical companies: Online Water Bioburden Analyzer (OWBA) Workgroup.  They outlined user requirements and a testing protocol to guide the development of an OWBA system. They believe, “an online water bioburden analyzer has the potential to eliminate sampling and testing errors via reduced manipulations while providing increased product safety and process control through the availability of statistically significant data.”

The purpose of an OWBA system isn’t to replace compendial water testing, but to reduce risk. Some potential benefits include:

  • Energy savings via reduced sanitization cycles and the operating temperature of the hot water system
  • Labor reduction through online monitoring and water system optimization, decreasing the frequency of sampling and lab-based testing.
  • Faster remediation response
  • Fewer investigations
  • Real-time monitoring that results in better process understanding and product safety

 

To learn about a laser-induced fluorescence method that may satisfy the OBWA requirements, read this article from www.cemag.us. For questions about cleanroom validation or certification, contact Gerbig Engineering Company. Call us at 88-628-0056 or email info@gerbig.com.

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 hazardous conditions, like during fumigation. Additionally, they are resistant to chemicals.

Compact seals are simple yet reliable, making them viable options for cleanroom sealing. Their efficient design makes them lightweight and fully mechanical. With a clean surface finish, they are resistant to vapor phase hydrogen peroxide, formaldehyde, and other fumigants typically used in contained rooms.

Compact seals allow changes to be made, like new services added, because of their practicality. Compact sealing units allow you to seal multiple cables in the same opening rather than making separate holes for each. When services are added to rooms, there is no need to drill and cut in a live room. Most often, they yield great first time validation results.

The compact seals complement modular cleanroom designs and their potential for expansion. They work well in any cleanroom, providing an economical and successful means of sealing leaks in a controlled environment. For questions about cleanroom verification and certification, contact Gerbig Engineering Company. Our experts have handled cleanroom equipment and services for thirty years. Contact us at 888-628-0056 or email info@gerbig.com.