Pharmaceutical Cleanroom: Lead Generation Challenges in 2023
- Oksana Kryvenchuk
- Sep 5, 2023
- 9 min read
Updated: Nov 3, 2024
Introduction
Cleanrooms plays a vital role in the world of biopharmaceutical R&D and manufacturing. It's all about creating a clean and safe environment for high quality and regulated products such as human drugs. But the sales and business development process required for cleanroom technologies can be a time and resource intensive activity. In this article, we will take a closer look at the hurdles faced by cleanroom tech providers in 2023, and how to execute effective lead generation campaigns within this niche segment.
Table of Contents
What is a cleanroom anyways?
Cleanrooms are essentially controlled environments designed to minimize contamination (from things like dust, germs, and other unwanted particles) using special construction methods, advanced air filters, and very strict procedures.
In life sciences, you'll find cleanrooms in pharmaceuticals, biotech, research labs, hospitals, food production, and cosmetic manufacturing. They're absolutely critical components of the manufacturing process because they ensure that products are made with the highest quality and safety standards.
How Clean Is a Cleanroom? Well, very clean. A class 100 cleanroom has 100 particles per cubic foot. By comparison your typical office space has between 500,000 and 1 million particles per cubic foot. Cleanrooms come in different classes from class 100 to 100,000.
Cleanrooms for Life Science Applications
A cleanroom is a room that has HEPA filtration to remove particles from the air. Cleanrooms are used for life science manufacturing where high levels of cleanliness and sterility are required. Common applications are medical devices, pharmaceutical and semiconductor manufacturing.
Pharmaceutical manufacturers are subject to FDA validation of their manufacturing which typically specify use of a clean room to ensure the quality of the manufactured pharmaceutical product. Sterility is highest priority. Pharmaceutical cleanrooms focus on both non viable (inanimate) and viable (live) contamination. They typically use laser particle counters to measure non viable contamination levels and settling plates with culture media to measure viable contamination levels. Pharmaceutical cleanrooms use aggressive chemical and UV light cleaning techniques to maintain sterility.
The systems and technologies that help cleanrooms maintain high standards of quality and safety include:
Air filtration: In biotech cleanrooms, the focus is on maintaining high air quality by using advanced multi-stage HEPA filtration and a special laminar air flow pattern. Ensuring high air quality is not just a recommendation, it's a fundamental requirement. The ISO standards lay out clear instructions for maintaining air quality. To put it simply, these standards mandate pharmaceutical companies to measure the concentration of particles in the air and ensure they fall within a specific range.
HVAC: Biotech cleanrooms often need a robust HVAC system to keep the temperature and humidity at the right levels.
Pressurization: In some biotech cleanrooms, there is an additional need to control air pressure. There are two types of cleanrooms, positive pressure and negative pressure cleanrooms, each with various applications in biotech, from research to manufacturing for medical devices and food.
Meeting Regulatory Requirements
One of the obvious challenges in maintaining a cleanroom environment is ensuring compliance with regulatory standards. Keeping up with ever-evolving best practices, advancements in technology, and updates in regulations is an ongoing task. Given the sensitivity of these applications, it is imperative to establish and adhere to strict standards to achieve the highest level of cleanliness required for activities such as testing, treatment development, and compound discovery.
In biotechnology, most cleanrooms must conform to the ISO 14644-1 cleanroom classifications. ISO is the International Standards Organization. It has created the ISO 4644-1 Cleanroom Standards that describe the allowed number and size of particles and HEPA filtered air flow changes per hour meet ISO-4, ISO-5, ISO-6, ISO-7, and ISO-8 standard.
ISO Cleanroom Specifications
The ISO 1 specification for cleanrooms require less than 2 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter. An ISO 1 cleanroom typically has from 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors.It is the most clean of the cleanroom classification.
The ISO 2 specification for cleanrooms requires less than 11 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter. A IS0 2 cleanroom typically has 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors.It is the 2ndmost clean classification.
The ISO 3 specification for cleanrooms requires less than 102 particles greater than 0.3 microns and no more than 8 particles greater than 1.0 microns per cubic meter. A IS0 3 cleanroom typically has 500-750 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors.It is the 3rd most clean classification.
The ISO 4 specification for cleanrooms requires less than 1020 particles greater than 0.3 micronsand no more than 2 particles greater than 5.0 microns per cubic meter. An IS0 4 cleanroom typically has 500-600 air changes per hour and typically utilizes ULPA filtration. Other common characteristics are 100% ULPA ceiling coverage and raised floors.It is the 4th most clean classification.
The ISO 5 is a super clean cleanroom classification. A cleanroom must have less than 3,520 particles >0.5 micron per cubic meter and 250-300 HEPA filtered air changes per hour. The equivalent FED standard is class 100 or 100 particles per cubic foot. Common applications are semiconductor manufacturing and pharmaceutical filling rooms.
The ISO 6 is a very clean cleanroom classification. A cleanroom must have less than 35,200 particles >0.5 micron per cubic meter and 180 HEPA filtered air changes per hour. The equivalent FED standard is class 1000 or 1000 particles per cubic foot.
The ISO 7 is a common clean cleanroom classification. A cleanroom must have less than 352,000 particles >0.5 micron per cubic meter and 60HEPA filtered air changes per hour. The equivalent FED standard is class 10.000 or 10,000 particles per cubic foot. Common applications are pharmacy USP800 compounding rooms, electronics manufacturing and medical device manufacturing.
The ISO 8 is the least clean cleanroom classification. A cleanroom must have less than 35, 200,000 particles >0.5 micron per cubic meter and 20 HEPA filtered air changes per hour. By comparison a typical office space would be 5-10 times more dirty. The equivalent FED standard is class 100,000 or 100,000 particles per cubic foot. Common applications include plastic extrusion for medical devices, e-liquid manufacturing, and nutraceutical packaging.
The Challenges of Cleanroom Technology Providers
Growing competition
The global cleanroom technology market is relatively small and made up largely of local companies. These companies are increasingly teaming up, buying each other, and launching new products. They're also spending time and effort on research to make their products and services work better.
Within the next 5-10 years, we will likely see more cleanroom "on-demand" solutions. These will become more common and fit into the market for clean manufacturing spaces, just like the ones made in-house or by Contract Development and Manufacturing Organizations (CDMOs).
We'll also see more and more cleanroom companies offering flexible services, with modular setups to adjust to customers' changing needs and deal with the unpredictability of project schedules. These setups can be designed to fit almost any kind of floor plan, both horizontally and vertically.
As the economic pressures increase, some customers might be tempted to look for cheaper manufacturing options, or even consider purchasing used equipment. Of course, selecting equipment and furniture made with less sturdy materials or that has been damaged by harsh cleaning chemicals can be very risky, and end up costing more in the long run.
Capital investment
One of the biggest challenges with selling cleanroom technology is the upfront capital investment incurred by R&D laboratories and manufacturers. Establishing cleanroom facilities requires significant costs in designing, developing, and maintaining cleanrooms.
Cleanrooms rely on high air circulation and energy-intensive processes which can result in operating costs that are up to 100 times higher than those of regular commercial facilities.
Additionally, cleanrooms operate round-the-clock, contributing to peak electricity demands. Cleanroom technology involves various components, filtration systems, air handling units, laminar flow workstations, gowning systems, and flooring systems. This specialization and complexity drive up the overall cost of cleanroom technology, creating a financial hurdle for companies, especially smaller ones, looking to invest in such systems.
Building an ISO 7 to ISO 8 biopharma cleanroom can range from $250 to $1,500 per square foot due to the use of corrosion-resistant stainless steel. Many facility managers are turning to modular construction as a cost-saving measure. These high costs are often a deterrent for companies contemplating cleanroom investments, leading to extended sales cycles. Therefore, it is important for cleanroom manufacturers to carefully qualify each lead before investing too much time in lengthy sales discussions that are doomed to disappoint all stakeholders involved.
Lead generation
Beyond dealing with intense competition and substantial expenses, cleanroom technology providers frequently interact with clients who have multiple projects in various parts of the world. This circumstance can pose a significant challenge for cleanroom companies because problems in one location may negatively impact the overall client relationship. Over-reliance on a limited number of clients is especially worrisome in specialized niche sectors such as biotech, where the potential market size is more constrained.
To mitigate these risks, cleanroom providers should establish comprehensive strategic and tactical plans to diversify their portfolio of projects and client base while maintaining a consistent stream of new leads.
Why Outsourcing Lead Generation to Outbound Pharma
Industry segment know-how
Life science consultants at Outbound Pharma understand that every cleanroom technology is unique, and a one-size-fits-all approach doesn't cut it. Our expertise lies in crafting targeted lead generation strategies that align with your commercial needs. For instance, we've helped cleanroom companies by developing strategies that focus on targeting specific industry segments (e.g. cancer immunotherapy companies or cell therapy drug discovery companies) and personas. These customized approaches have consistently delivered the highest reply rates in the industry. When partnering with Outbound Pharma, you can expect a tailored lead generation campaign that addresses your distinct value proposition, challenges and opportunities, as we are backed by a track record of success in this segment.
Established network
Building and maintaining strong relationships with biopharmaceutical companies is crucial to our business. Trust and rapport play a significant role in our success as a lead generation consultancy. We prioritize building and maintaining valuable client relationships. Our approach involves active listening, clear communication, and a deep understanding of our clients' needs. By focusing on trust and rapport, we ensure that our clients not only receive the best cleanroom technology solutions, but also feel confident in their choice of a partner.
Life sciences expertise
Within the biotechnology and pharmaceutical industries, Outbound Pharma stands as your trusted partner. We bring forth a wealth of knowledge and experience in the following sectors: Industrial Biotech, Pharmaceuticals and R&D labs.
Industrial Biotechnology. Outbound Pharma has the expertise to assist you in prospecting and qualifying leads within the industrial biotech and agrochemical sectors. Specialty chemicals play an important role as essential components in various end products. These encompass advanced pharmaceutical ingredients (known as APIs), high-quality nanomaterials, additives for food, flavorings, fragrances, performance-enhancing fibers, paints, pigments, and substances used in industrial biotechnology and agricultural chemicals. :
Algae and its byproducts used in cosmetics, animal feed, and food production.
Producers of amino acids and enzymes for animal feed.
Biorefineries focused on sugar, starch, and bioethanol production.
Manufacturers of organic and fatty acids.
Development of bioplastics and surfactants for detergent applications.
Utilization of yeast, fungi, and bacteria for food industry purposes.
Representative companies in the industrial biotech sector include: Titan Agro, Agrana, BASF, Bayer, Cargill, Chr. Hansen, Clariant, ICM, Kemin, Tereos Syral among others.
Pharmaceuticals. Our consultants know the ins and outs of the pharmaceutical industry, covering a wide spectrum of segments, from pharmaceutical production, including API synthesis, fill & finish, solids production and personalized medicine therapies. Regardless of the scale of your projects, our lead generation consultants are well-equipped to help you secure new sales opportunities.
We helped clients secure meetings for the following projects:
A cleanroom installation project for lyophilizers in the USA.
GMP-compliant production plant for APIs in Europe.
An animal breeding center project in the USA.
A medical device manufacturing facility in Southeast Asia.
R&D laboratories. R&D labs also need to meet a variety of complex requirements, ranging from safety standards to hygiene levels. Whether your prospect is planning to build a new lab facility or to renovate an existing one, there are numerous factors to take into account, and of course it will depend on the type of laboratory: safety laboratories, quality control labs, basic R&D labs, pharmacies etc. Our lead generation expertise helped our clients secure new projects, including a new production building and laboratory project in Europe, or the development of hospital pharmacies across multiple European countries.
Key takeaways
In summary, the cleanroom technology industry faces challenges such as fierce competition, high capital investment costs, and complex lead generation within the biopharmaceutical sector. To overcome these hurdles, outsourcing lead generation to experts like Outbound Pharma, with their industry-specific knowledge, established networks, and life sciences expertise, can help companies thrive in this evolving landscape. Careful lead qualification and the flexibility to adapt to changing market dynamics are key to success in the cleanroom technology sector.
