Pharma's Growth Follows Innovation, Compliance, and Strategy

Q: What prompted T5DC to explore new sectors? What potential do you see in the medical device industry considering the recent regulatory changes in Mexico?

A: T5DC traditionally focused on the pharmaceutical industry, but we decided to explore new sectors due to our adaptable products and equipment. We are now targeting opportunities in the metal-mechanic, optical, and medical device sectors. Mexico has emerged as the 10th largest manufacturer of medical devices, prompting regulators to tighten oversight. Last November, they mandated compliance with Mexican regulations for manufacturers operating in the country even if their products are primarily exported to the United States. Given the critical importance of processes like cleaning and sterilization in medical device manufacturing, we see significant potential in this sector. We focus on products such as implants, needles, and glasses, all of which require stringent cleaning and sterilization procedures.

Q: What advances have you seen in the transition from manual to automated product cleaning?

A: The transition away from manual product cleaning has been challenging, primarily due to cultural factors deeply ingrained in Mexico's work practices. Despite efforts spanning over 20 years, there is still resistance to adopting automated processes. In sectors like healthcare, where cleaning is paramount, there is often a lack of understanding regarding the importance of thorough cleaning before sterilization. Some view manual cleaning as sufficient, ignoring the risk of contamination and the necessity of proper sterilization procedures. Cost considerations also present a significant barrier, as manual labor is perceived as cheaper than investing in equipment. However, manual cleaning is not only less effective but also uses a lot more resources, such as water, cleaning agents, and most of all, time consuming. It also leads to increased material damage.

Convincing stakeholders, particularly management and finance teams, of the long-term benefits of automated cleaning requires extensive education and training to facilitate the transition to automated processes.

Q: Having been in business for 30 years, what do you consider to be the company's unique value proposition?

A: The key to maintaining our strong customer loyalty lies in our commitment to understanding and addressing clients’ needs effectively. We prioritize offering exceptional support. Despite market pressures on pricing, we remain steadfast in our dedication to quality and service. A recent example of this commitment is evident in our approach to passivation processes for pharmaceutical water systems. While traditional methods use significant quantities of harsh acids, we offer alternative solutions that require minimal chemical usage yet deliver superior results. Despite the higher initial cost, our approach ensures long-term efficiency and minimizes contamination risks. This exemplifies our belief that prioritizing quality over short-term cost savings ultimately benefits both our customers and our business.

Q: How is the company adapting to the evolution of Pharma 4.0? What strategies are you putting in place to ensure alignment with industry advances?

A: In adapting to the evolution of Pharma 4.0, T5DC prioritizes staying abreast of both national and international regulations to ensure compliance. Our equipment, primarily our high-tech solutions, is carefully selected to align with the latest advances in technology. For example, our distribution of Sievers Total Organic Carbon (TOC) equipment has evolved from Generation 800 to Generation M9, reflecting advances in speed, data accuracy, and automation capabilities with the integration of platform Data share Elite (DSE). These newer generations enable faster results, enhanced data management through Supervisory Control and Data Acquisition (SCADA) or Laboratory Information Management Systems (LIMS), and long-term storage of analytical information, meeting regulatory requirements that demand retention of data for up to five years. By integrating cutting-edge technology and maintaining regulatory compliance, we empower pharmaceutical companies to meet global standards while enhancing efficiency and data management practices.

Q: What regulatory measures are necessary for promoting sustainable growth within the pharmaceutical industry?

A: Mexico needs regulations that prioritize automation and expertise to foster sustainable growth in the pharmaceutical industry. Observations from various sectors highlight the need for regulatory systems to evolve toward greater automation while retaining experienced personnel. The loss of seasoned experts in the pharmaceutical industry makes it challenging to uphold standards effectively. Experience plays a crucial role in understanding and implementing regulations, especially concerning manufacturing processes. Automation is also essential to streamline processes and ensure efficiency, particularly in the face of complex regulatory requirements.

During the pandemic, regulatory shortcomings were observed as the emergency overrode standard procedures, resulting in the importation of medicines without proper review. This underscores the urgent need for robust regulatory systems to prevent such lapses and ensure patient safety. Addressing these issues will be pivotal in promoting sustainable growth within the industry.

Q: What are the company's long-term goals and plans for the longer term?

A: The company's long-term goals involve venturing into new areas, primarily focusing on manufacturing metal mechanical pieces to address market demand for faster availability. The company is in the process of securing a new facility and investing in machinery, such as plasma cutting systems, to kickstart this initiative. There is also a strategic emphasis on expanding into the medical device market, with dedicated personnel hired for this purpose. By diversifying into these sectors, the company aims to enhance its presence beyond pharmaceuticals and become more visible in the metal-mechanic and optics sectors, ensuring sustainable growth and meeting evolving customer needs.

It is crucial to continuously advance and remain open to new technologies, always seeking ways to enhance processes. Automation plays a vital role in the pursuit of improvement.

T5DC is a Mexican distributor of equipment for pharmaceutical, pharmachemical, and biotechnology companies. It has over 25 years of experience, and also offers training courses in good manufacturing practices, cleaning processes, and good laboratories practices