New Technology Facilitates Sanitation, ValidationBy Alicia Arizpe | Wed, 09/09/2020 - 13:17
Q: What are the main advances T5DC has made over its 25-year history?
A: Pharmaceutical companies must wash, clean and sanitize all the equipment involved in production of medicines to ensure their safety, purity and effectiveness. Our challenge for the past 25 years has been to change the culture that washing or cleaning has to be done by hand. Plant operators and managers often believe that it is less expensive to hire people to wash the equipment in eight-hour shifts than buying a washing or drying equipment. However, plants can easily make up for the costs of new equipment just through their savings on labor, detergents and water over a year. Moreover, hand-washing often leads to damage and broken materials and equipment parts, that must to be replaced at significant cost, which does not happen with our washing machines.
The equipment we offer allow users to control all inputs, such as water flow, total water use, detergent and neutralizing volume, times, temperatures and drying times using twice- HEPA filtered, heated air. This cleaning process is much more efficient than washing by hand in terms of time, water and cleaning products consumes.
Q: What products does T5DC offer in Mexico and how do they benefit the pharmaceutical industry?
A: We offer Steelco’s automated washing equipment, Borer Chemie’s chemical cleaning agents and neutralizers and Suez’s Total Organic Carbon (TOC) analyzers. This last brand, which are now our highest-selling products, are used to analyze and control all water used at pharmaceutical plants to determine the amount of organic and inorganic impurities present as residuals. By law, pharmaceutical companies must analyze all these water residues, an analytical process that was previously done with semi-quantitative analysis, and would take around four hours. We started representing Suez’s TOC analyzers in 1996 and they are now in the fourth generation, becoming progressively faster and more efficient. Now, this process can be automated with simultaneous TOC and conductivity tests every two minutes, allowing users to make much faster decisions.
We are also a supplier of Comecer isolators, which are inert atmosphere glove boxes used to handle products that are sterile, sensitive to ambient moisture and other air particles or high-risk products that are dangerous for the user due to their high pharmacological activity and cytotoxicity. These chambers have to be sanitized with Vapor of Hydrogen Peroxide (VPHP), which allows us to go from an air purity Class D area (high amount of viable and non-viable particles) to a class A area (lowest amount of viable and non-viable particles). This jump saves the customer several steps, spaces and monitoring of rooms that would go from class D to C to B and finally to A. The use of our isolators allows clients big savings in energy consumes and space, increasing safety to the product and the operator.
Q: How are you increasing awareness of the benefits these products offer to the pharmaceutical industry?
A: We participate in several Pharma forums, Symposia and UNAM’s Post-graduate School of Chemistry courses related to cleaning validation. Our most significant work, is with the financial areas of our potential clients. Pharmaceutical companies must validate the trustworthiness and reproducibility of all processes and all products they will release to the market. There are also strict regulations concerning to the validation of the cleaning process to avoid cross contamination of an specific medications that could cause significant health problems. International regulations concerning the production of pharmaceutical products, have helped to increase awareness of the importance of better control and automation in their manufacturing processes. Mexico is increasingly embracing these technologies. Some national pharmaceutical companies, such as Pisa Farmaceutica, Silanes, Senosiain, Liomont, Ultra and Chinoin, are now spearheading the adoption of these state-of-the-art technologies.
Q: Which new technology trends are you seeing in pharmaceutical manufacturing?
A: Track-and-trace technology is critical to the pharmaceutical industry. As the pharmaceutical industry grows, so does counterfeiting. The industry has invested significantly to stay ahead of pirates by modifying labels, dosages systems and packages, but what is increasingly more popular is the incorporation of traceability measures that allow companies to identify a medication at every step, from the second it leaves the manufacturing plant to the moment it reaches the final consumer, wherever they are located.
Another growing trend are isolator systems. Medicines in Mexico and the world, are becoming more specialized as personalized and genomic medicines gain strength. These products require smaller production volumes but very delicate management that will involve isolation technology.
Q: What have been T5DC’s priorities during 2020?
A: In January 2020, we introduced Dec Group’s equipment for powder handling in containment, which is broadly used in the pharmaceutical industry to facilitate the management of powder excipients and active ingredients. During the COVID-19 outbreak, we focused on providing maintenance to our client’s equipment as our business is essential to the proper functioning of pharmaceutical operations. We could not allow a production plant to stop because it lacked access to the necessary services. This will continue to be our priority for 2020. We have sold isolators, washing machines and TOC analyzers during this period.
T5DC is a Mexican distributor of equipment for pharmaceutical pharmochemical and biotechnology companies with 25 years of experience. The company offers training courses in Good Manufacturing Practices, Cleaning process and Good laboratories Practices