PodTech’s cleanroom revolutionising pharmaceutical manufacturing in LMICs


The African Society for Laboratory Medicine, in their study, highlighted the significance of cleanroom hazards and mentioned that DRI scores derived from 12 of the 14 African countries demonstrate the presence of AMR as a substantial threat. It is worth noting that all assessed countries scored at least twice the benchmark of 25%. However, only 1·3% of the diagnostic laboratories in sub-Saharan Africa currently possess the capability to perform clinical bacteriology in a cleanroom environment.

Challenges Faced by LMICs in Accessing Quality Culture Media in the Absence of Local Cleanroom

One of the key challenges faced by LMICs (Low- and Middle-Income Countries) is the scarcity of local companies and supply chain issues, which make ready-to-use, quality-assured culture media either excessively expensive or completely unavailable. This unavailability of culture media emphasises the urgent need for local production of high-quality products at affordable prices, especially in a cleanroom setting. However, producing culture media is a demanding and complex task, particularly in laboratories situated in LMICs.

These laboratories encounter additional challenges due to harsh environments characterised by heat, dust, and humidity. Moreover, faulty infrastructure, such as poor access to clean water and an unreliable power supply, further hinders their operations. The ill-maintained equipment poses another obstacle to their ability to produce culture media that meets international quality standards, especially considering the requirements for a cleanroom environment.

The Role of PodTech’s Podule™️ in Combating Infrastructure Challenges

PodTech can play a crucial role in combating the challenge of limited access to quality culture media for diagnostic laboratories in sub-Saharan Africa and other LMICs. By leveraging its innovative Podule™️ technology and expertise in pharmaceutical manufacturing, PodTech can contribute to the local production of high-quality, ready-to-use cleanrooms in the pharmaceutical industry at affordable prices.

Achieving Health Equity with PodTech’s Podule™️ Technology in LMICs

The innovative technology of PodTech’s Podule™️ holds immense potential to contribute to achieving health equity in LMICs. These self-contained units, housed within shipping containers, offer a fast, flexible, and scalable solution that can revolutionise the healthcare infrastructure in resource-constrained settings.

Assembled offsite at a cutting-edge manufacturing facility in the UAE, the Podules™️ are designed to have an operational life of over 20 years. With dedicated air handling, building management systems, fire protection, and utility distribution, these self-contained units provide a comprehensive solution for various manufacturing needs, including biopharma, fill and finish, inhalation, onco, and novel products. Regulatory bodies such as the USFDA, MHRA UK, and EU GMP have recognised and accepted this factory system, ensuring compliance with international quality standards. The pre-validation process conducted before shipping guarantees regulatory compliance and gives reassurance of the system’s reliability.

The Podule™️ deployment process is streamlined, requiring only basic utility connections and electricity at the factory site. This ease of installation reduces the barriers to entry, allowing LMICs to swiftly establish pharmaceutical manufacturing capabilities and meet the healthcare demands of their populations.

Furthermore, Podules™️ are designed to operate continuously, 24×7, throughout the year, and come with power backup systems, ensuring uninterrupted production and supply of essential medications. Additionally, the modular nature of the factory system allows for flexibility, with smaller units easily mounted on plinths and wheels, enabling relocation as per the changing needs of the healthcare infrastructure.

By implementing PodTech’s Podule™️ technology, LMICs can overcome infrastructure challenges, expedite local pharmaceutical production, and enhance access to quality healthcare products. This transformative solution brings us closer to achieving health equity by empowering countries to provide affordable and reliable medications to their populations, ultimately improving health outcomes and reducing disparities.

Podule™️ Technology: Mitigating Harsh Conditions and Enhancing Local Pharmaceutical Production

PodTech’s Podule™️ can provide a controlled environment that can mitigate the harsh conditions typically found in LMICs, such as heat, dust, and humidity. The reinforced steel structure and stringent quality control measures ensure that the production process takes place in a clean and regulated space, meeting international quality standards for culture media.

Moreover, they offer modular prefab construction, making it easier to set up and operate even in areas with limited infrastructure. This addresses the challenge of faulty infrastructure by providing laboratories with a self-contained production facility that doesn’t rely heavily on external resources like clean water and uninterrupted power supply.

PodTech’s expertise in pharmaceutical manufacturing and quality control processes can further assist laboratories in producing culture media that meet international standards. By enabling local production of cleanroom, PodTech helps address the supply chain issues and scarcity of affordable, quality-assured products in LMICs. This empowers diagnostic laboratories to enhance their capabilities in clinical bacteriology, improving their capacity to diagnose and combat antimicrobial resistance (AMR). It also reduces their dependence on first-world countries, making these essential resources more accessible and affordable for laboratories in sub-Saharan Africa and other LMICs.

Improving Quality Standards and Self-Reliance with Local Cleanroom in LMICs

In the field of drugs/pharmaceuticals research and development (R&D), the role of cleanroom design is crucial to ensure the safety, quality, and efficacy of the products being developed. Cleanroom in pharmaceutical industry allows a controlled environment that minimises contamination from particles, microorganisms, and other pollutants that could potentially affect the integrity of drugs and pharmaceuticals. Cleanroom provides a sterile and controlled atmosphere necessary for various processes, including the manufacturing, testing, and packaging of drugs.

LMICs can ensure high-quality standards in pharmaceutical manufacturing by developing local cleanrooms. The controlled environment will help ensure the purity, potency, and safety of drugs. By establishing local cleanroom, LMICs can enhance their capability to produce high-quality pharmaceuticals that meet international standards, increasing patient safety and improving the reputation of their pharmaceutical industry.

Local Cleanrooms: Meeting Regulatory Requirements and Boosting Pharmaceutical Industry

Regulatory bodies, such as the Food and Drug Administration (FDA), USA and European Medicines Agency (EMA), have stringent guidelines for pharmaceutical manufacturing. These guidelines often mandate the use of specific cleanroom design to ensure compliance with good manufacturing practices (GMP). Developing local cleanrooms enables LMICs to meet these regulatory requirements, facilitating exports to international markets and expanding their pharmaceutical industry.

Empowering Research and Development Capabilities with Efficient Cleanroom Design

In order to improve the self-reliance in LMICs, the countries need to be able to formulate existing and new drugs, analyse samples and conduct experiments. Having efficient cleanroom design LMICs can foster their own research and development capabilities, enabling them to innovate, discover, and address health challenges specific to their population.

Reducing Dependence on Imports and Enhancing Accessibility of Medicines in LMICs

The import of pharmaceutical products is also an expensive affair, and by developing local cleanroom, LMIC can reduce their dependence on import, and by manufacturing drugs locally, they can eliminate or reduce transportation costs, import duties, and other expenses associated with importing drugs. As a result of which, more affordable and accessible medicines for their population can be made available, healthcare outcomes can improve, and most importantly, the burden of disease can be reduced.

Enhancing Preparedness and Rapid Response with Local Cleanrooms in Public Health Emergencies

The local cleanroom will also contribute to LMICs’ preparedness in handling public health emergencies, such as disease outbreaks or pandemics. In such situations, having the infrastructure and capacity to rapidly produce and test pharmaceuticals in a controlled environment is crucial. Having local cleanrooms enable LMICs to respond swiftly to emerging health threats, ensuring the availability of essential drugs and medical supplies.

Cleanroom Infrastructure: Promoting Skill Development and Economic Growth in LMICs

Apart from evident public health benefits, by investing in cleanroom infrastructure, LMICs can promote skill development in pharmaceutical sciences, engineering, and related fields. This, in turn, creates job opportunities and fosters the growth of a skilled workforce, contributing to economic development and reducing unemployment rates.

PodTech’s Podule™️ technology and expertise offer a transformative solution to address the challenge of limited access to quality pharmaceuticals in LMICs. By establishing local production capabilities, PodTech empowers laboratories to overcome supply chain issues, enhance diagnostic capabilities, and combat the significant hazard of antimicrobial resistance in a more sustainable, cost-effective manner and in a fraction of the time in comparison to traditional infrastructure.

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