Japan-Made Supplements and Cosmetics Earn Global Trust: The Fusion of Quality Control Systems and Artisanal Techniques
Introduction
In 2022, supplement exports from Japan reached 33.1 billion yen, achieving a remarkable growth of 44 per cent compared to the previous year. Demand for Japanese-made supplements and cosmetics in Asian markets, centred on China, Taiwan, and Vietnam, has been rising year by year.
Behind this growth lies more than simply the brand power of 'Made in Japan'. Japan's unique quality control systems, fermentation techniques inherited over decades, and the craftsmen's attitude of relentlessly pursuing 'perfection' have earned absolute trust from buyers around the world.
What distinguishes Japan's supplement and cosmetics industry in the global market is its thorough commitment to quality throughout the manufacturing process. Whilst many countries place emphasis on final product inspection, in Japan consistent quality control is carried out from the selection of raw materials through each stage of the manufacturing process to post-shipment follow-up. This approach has emerged from the traditions of Japanese manufacturing cultivated over many years and from a corporate culture that places consumer safety first.
This article examines Japanese supplements through case studies of three small and medium-sized enterprises.
Chapter One: The GMP Certification System − The 'Absolute Assurance' Generated by Japan's Quality Control Systems
1.1 Why Are Japanese Supplements Trusted?
The greatest distinguishing feature of Japanese supplement manufacturing is the voluntary adoption of pharmaceutical-grade quality control standards. Whilst regulations for health food manufacturing are relatively lenient in many countries, Japanese manufacturing companies as an industry have imposed stricter standards upon themselves.
At the core of this approach lies a quality control system called GMP (Good Manufacturing Practice). GMP refers to manufacturing process management standards necessary to ensure products are made 'safely' and that 'consistent quality' is maintained throughout all processes, from the receipt of raw materials through manufacturing to the shipment of final products.
In Japan, the health food GMP certification system commenced in 2005. This system applies rigorous management methods used in pharmaceutical manufacturing to the health food sector, covering every aspect from hygiene management on the manufacturing floor to document management. Today, many manufacturing companies have obtained this certification and meet international quality standards.
The management requirements demanded by GMP are wide-ranging, but their essence lies in 'making all manufacturing processes visible, recorded, and verifiable'. First, it confirms that the correct raw materials are used and that the quantities contained in products are accurate. Component analysis is conducted from the raw material stage to scientifically prove that quality matches what is indicated.
Next, it thoroughly manages whether manufacturing takes place in a hygienic environment. Everything is specified in detail, from the cleanliness of manufacturing facilities to the hygiene conditions of workers and the cleaning methods for equipment used. What most surprises overseas buyers visiting Japanese factories is the thoroughness of this hygiene management. Workers wear dedicated cleanroom attire and pass through air showers before entering manufacturing areas. Air inside manufacturing rooms is constantly filtered, whilst temperature and humidity are strictly controlled.
Furthermore, prevention of foreign matter contamination and prevention of product mix-ups are also important management items. Manufacturing lines employ metal detectors and X-ray inspection machines, missing no foreign matter however slight. Additionally, when manufacturing multiple products, cleaning and verification during line changeovers are thorough to ensure no components from previous products remain.
Product uniformity is also rigorously checked. For products from the same lot, the quality must be identical regardless of which container is opened. For this reason, samples are collected periodically during manufacturing and analysed for component content, dissolution properties, and such. Statistical methods are employed to confirm that product variation falls within acceptable ranges.
Quality assurance within the best-before date is also a field to which Japanese companies devote particular effort. Products are stored for extended periods under actual storage conditions, or under more stringent conditions, and quality maintenance is scientifically demonstrated. These stability tests may require several months to several years, but they are an indispensable process for reliably delivering quality to consumers.
All manufacturing process and quality control records are created in detail according to regulations and stored for extended periods. Everything is traceable: when, who, which raw materials were used, and under what conditions manufacturing took place. Even if problems occur, by tracing back through these records the cause can be identified and only the relevant lot can be swiftly pinpointed.
Before shipment, multiple-stage checking systems are established to prevent substandard products from reaching the market. Final inspections evaluate products from every angle, including visual inspection, weight inspection, and component analysis. Only products that clear all standards are permitted for shipment.
Finally, response systems after products reach the market are also in place. Samples from each lot and manufacturing records are stored so that enquiries and complaints from consumers can be addressed swiftly. If quality concerns are raised, stored samples can be analysed and manufacturing records verified, enabling objective examination.
1.2 The Turning Point of 2024: From Recommendation to Obligation
In 2024, the Japanese government decided upon a policy to mandate manufacturing process management through GMP for supplements designated as Foods with Function Claims. This represents a historic turning point for Japan's health food industry.
Previously, GMP had been operated as a voluntary certification system by industry associations. Whilst many companies had obtained certification, it was not a legal obligation. However, from the perspective of consumer protection and with the aim of strengthening international competitiveness, the government has embarked upon stricter regulation.
This mandating represents an extremely stringent standard even by global standards. Whilst the United States has GMP regulations for dietary supplements, Japan's standards possess an equivalent or even greater degree of rigour. Europe and many Asian countries do not require such strict manufacturing management for health foods. Japan has become one of the few countries in the world to manage health foods at a quality level approaching that of pharmaceuticals.
This development has further reinforced quality assurance for Japanese-made supplements. For foreign buyers, this holds very significant meaning. It means that 'simply by sourcing from Japan, one automatically obtains world-leading quality assurance'.
If one were to attempt to establish a stringent quality control system in one's own country, considerable investment and time would be required. Renovation of manufacturing facilities, introduction of inspection equipment, securing of specialist personnel, construction of management systems—for small and medium-sized enterprises these represent substantial burdens. However, by procuring products from Japan, one can obtain products made in factories where all of these elements are already in place.
Furthermore, GMP mandating becomes a powerful weapon when appealing product reliability to consumers. Along with heightening health consciousness, consumers worldwide are becoming more sensitive to product safety and quality. The fact that a product is 'manufactured under Japanese GMP standards' becomes a major marketing advantage. Indeed, in affluent consumer markets in China and Southeast Asia, being Japanese-made has become an important element justifying price premiums.
For Japanese companies too, this mandating is by no means a negative development. Whilst obtaining and maintaining certification certainly entails costs, it raises the quality of the entire market and further solidifies the brand image of 'Japanese-made equals high quality'. The risk of quality problems by some companies damaging the reputation of the entire industry is also reduced.
Moreover, GMP mandating also has the effect of facilitating international transactions for companies contemplating overseas expansion. Whilst many countries require proof of manufacturing management standards for imported health foods, Japanese GMP certification is often accepted directly as a certificate of quality. Export procedures are simplified and negotiations with overseas buyers proceed more smoothly.
The reason Japan's supplement industry is so particular about quality control extends beyond simply responding to regulations. At its foundation lies a sense of mission to protect consumer health and the craftsman's spirit of 'making good things' that Japanese manufacturing has cultivated over many years.
Chapter Two: Mitsubishi Gas Chemical's 'BioPQQ' − Building Trust Through Fermentation Technology and International Certification
2.1 A Component Attracting Attention as the Fourteenth Vitamin
Mitsubishi Gas Chemical Company, Inc., headquartered in Marunouchi, Tokyo, is a company that has contributed to society through chemical technology since its establishment in 1951. The company, which handles a wide range of chemical products including methanol and engineering plastics, applied chemical technologies it had accumulated over many years to establish the world's first mass production system for food-grade PQQ.
'BioPQQ® (pyrroloquinoline quinone disodium salt)', developed by the company, is a component of note that was discovered in 1979 and indicated as a 'potential fourteenth new vitamin' in the scientific journal Nature in 2003. This proprietary material has been approved as a novel food ingredient in Europe and America as well, and is currently also being utilised in research on brain function and antiviral properties.
PQQ possesses the action of increasing 'mitochondria', the organelles within cells that produce energy, and enhancing their function. Mitochondria are also called the human body's energy production factories, and when their number or function declines, this leads to fatigue and decline in cognitive function. Research has revealed that by acting directly upon these mitochondria, PQQ demonstrates numerous bioactive properties including maintenance of cognitive function in middle-aged and older adults, antioxidant effects, and fatigue recovery.
Research institutions worldwide have focused attention on the health benefits of PQQ, and the number of papers is increasing year by year. However, to provide these effects as actual products, technology to stably manufacture high-purity PQQ was indispensable. It was the accumulation of Japanese fermentation technology that solved this challenge.
2.2 Proprietary Fermentation Technology: The Crystallisation of Japanese Technical Prowess
Mitsubishi Gas Chemical's greatest strength lies in its ability to produce PQQ at high purity through proprietary fermentation technology. Whilst PQQ is also contained in vegetables and fermented foods, the quantities are extremely small. The amount of PQQ contained in one kilogramme of natto is approximately 60 microgrammes, and in parsley approximately 30 microgrammes—trace quantities. To obtain this from food would require continuing to consume impractical amounts.
Based upon microorganism cultivation technology accumulated over many years, Mitsubishi Gas Chemical succeeded in the world's first commercial production of PQQ. More than ten years were devoted to this technology development. It is a technology perfected through countless trials and errors, including selection of appropriate microorganism strains, establishment of optimal cultivation conditions, and development of efficient purification methods.
Manufacturing takes place in GMP-managed factories within Japan. In the fermentation process, dozens of parameters including cultivation temperature, pH, and oxygen concentration are strictly controlled. Because even slight changes in conditions affect product quality, monitoring is conducted on a twenty-four-hour basis.
Quality control is implemented at pharmaceutical-grade standards. From acceptance inspection of raw materials through quality confirmation during fermentation, purity checks during purification processes, and component analysis of final products, rigorous inspections are conducted at each stage. Complete traceability is ensured for each lot, providing consistent quality assurance from raw materials to final products.
Through this manufacturing system, BioPQQ® achieves high quality with purity exceeding 99 per cent. The risk of impurity contamination is minimised to the utmost, and quality variation between batches is also kept extremely small. Even when compared with competing overseas products, the stability of its quality is outstanding.
2.3 Clearing the World's Most Stringent Certifications
BioPQQ® has successively obtained certifications considered the world's most stringent. In 2008, its US FDA NDI (New Dietary Ingredient) notification was accepted, permitting its use in the American market. In 2014, Japan's Ministry of Health, Labour and Welfare approved its domestic use, enabling it to be officially sold in the Japanese market as well.
In 2017, it obtained US Self-Affirmed GRAS (Generally Recognized as Safe) status. GRAS certification is important certification indicating that a substance can be used in a wide range of applications as a food additive. This acquisition greatly expanded the scope of product development in America.
Particularly noteworthy is its receipt of Novel Food designation from the European Commission in 2018. Safety evaluation by the European Food Safety Authority (EFSA) is considered the world's most stringent, with thorough examination conducted in every aspect including presentation of scientific evidence, demonstration of long-term safety, and transparency of manufacturing processes. To date, only just over one hundred foods and food ingredients have been approved as Novel Foods. BioPQQ®'s clearance of this rigorous examination is proof that its safety and quality are of the world's highest standard.
Also in 2018, it obtained the anti-doping certification 'Informed Choice'. This certification guarantees that products do not contain substances prohibited by the World Anti-Doping Agency (WADA), indicating that even professional athletes can use them with confidence. It is rigorous certification that evaluates even contamination risks during the manufacturing process.
Obtaining these international certifications requires accumulation of vast safety data and scientific research to substantiate it. Mitsubishi Gas Chemical, in collaboration with universities and research institutions, has continuously conducted clinical trials and safety tests. As a result, it has become an ingredient trusted by regulatory authorities worldwide.
2.4 Business Opportunities: A Complete Support System
Mitsubishi Gas Chemical provides companies using BioPQQ® not merely with raw material supply but with comprehensive support from product development through to notification. Particularly for companies utilising Japan's Foods with Function Claims system, it provides a complete set of materials necessary for notification. These include safety test data, scientific evidence regarding functionality, and information concerning manufacturing processes.
Notification for Foods with Function Claims requires presenting detailed scientific evidence to the Consumer Affairs Agency, which represents a significant hurdle for small and medium-sized enterprises. However, when using BioPQQ®, the abundant data already accumulated can be utilised, substantially simplifying the notification process. Even when content updates are necessary after notification, continuous support is available.
Technical support is also substantial. From the product design stage, specialist advice is provided on matters including PQQ stability, interactions with other components, and optimal formulation quantities. Should technical challenges arise regarding formulation, Mitsubishi Gas Chemical's research and development team proposes solutions.
For foreign entrepreneurs, this represents the major advantage of being able to 'obtain Japanese high-quality raw materials and technical support as a package'. Without making vast research and development investments themselves, they can bring to market products using world-leading functional components.
Indeed, many overseas companies that have adopted BioPQQ® have succeeded in product differentiation. In the Chinese market, supplements promoting cognitive function support have gained popularity amongst the affluent. In America, products are developed as energy supplements for athletes. In Europe, they are accepted as health maintenance products for older adults.
What Mitsubishi Gas Chemical's case demonstrates is that Japanese companies' strengths do not lie merely in manufacturing technology. The source of competitiveness is comprehensive value provision: investment in long-term research and development, acquisition of international certifications, and generous support systems for client companies. This approach is a characteristic commonly observed in the companies introduced next as well.
Chapter Three: Kyowa Hakko Bio's 'Ornithine' − Purity and Trust Born from Sixty Years of Fermentation Technology
3.1 Pioneer of the Fermentation Method
Kyowa Hakko Bio Co., Ltd., headquartered in Nakano, Tokyo, inherited the fermentation technology of Kyowa Hakko Kogyo and currently operates as a biochemical company within the Kirin Group. The company is a global pioneer in amino acid fermentation, having succeeded in 1956 in the world's first mass production of amino acids through the fermentation method. Carrying on that tradition, it supplies internationally components for health enhancement applications, beginning with its principal material 'ornithine'.
At that time, methods of extracting amino acids from animal hair, soya beans, and such were mainstream, but Kyowa Hakko Bio established an innovative manufacturing method called the fermentation method, which uses the power of microorganisms. This technological innovation made mass production of amino acids possible and substantially lowered prices as well.
For more than sixty years since then, the company has continued to evolve its technology as a pioneer in the fermentation method and amino acids. One of the products in which these accumulated technologies and know-how have crystallised is ornithine.
Ornithine is known as a valuable health component contained in freshwater clams. Since long ago it has been said that 'after drinking alcohol, have clam soup', and as a component supporting liver health it has been familiar since the Edo period. However, obtaining sufficient quantities of ornithine from clams is not realistic. The ornithine contained in one hundred grammes of clams (approximately thirty-five clams) is only around 10 to 15 milligrammes. To consume quantities from which health benefits could be expected, one would have to continue eating large amounts of clams every day.
It was Kyowa Hakko Bio's fermentation technology that solved this challenge. Through the fermentation method using microorganisms, it achieved high-purity mass production that was impossible through extraction from foods.
3.2 Fermentation Technology Achieving 'The Equivalent of 1,800 Clams'
Kyowa Hakko Bio's ornithine supplement concentrates ornithine equivalent to approximately 1,800 clams in six tablets. What makes this remarkable concentration possible is fermentation technology refined over more than sixty years.
The company's fermentation method is a technology that maximally draws out the amino acid production capability possessed by specific microorganisms. First, from amongst thousands or tens of thousands of microorganisms, bacterial strains that efficiently produce ornithine are selected. Next, the conditions under which those strains most actively produce ornithine are identified. Countless combinations of cultivation temperature, nutrient formulation, fermentation time, and such are tested to establish optimal conditions.
This fermentation method possesses overwhelming advantages compared with extraction methods from clams. First, it can stably supply high-purity (exceeding 99 per cent) L-ornithine. Whilst natural clams have component content that varies according to growth environment and season, the fermentation method can maintain consistently uniform quality. Because microorganisms are cultivated in strictly managed environments, there is no quality variation.
Moreover, the fermentation method is also a sustainable production method with low environmental burden. Whilst large-scale harvesting of clams would raise concerns about ecological impact, with the fermentation method there is no worry of depleting natural resources. The raw materials used are also simple items such as carbohydrates and nitrogen sources.
In Kyowa Hakko Bio's factories, an integrated production system from fermentation through purification to formulation has been established. In fermentation tanks, temperature, oxygen concentration, and such are automatically controlled, enabling microorganisms to produce ornithine in optimal conditions. After fermentation concludes, through advanced purification technology impurities are removed and ornithine of purity exceeding 99 per cent is extracted. This purification process also applies technology cultivated in pharmaceutical manufacturing.
3.3 Thorough Safety Testing
Kyowa Hakko Bio has accumulated abundant data on the safety of ornithine. When bringing new health food components to market, scientific proof of safety is indispensable. The company has conducted pharmaceutical-grade safety tests including thirteen-week repeated dose toxicity studies, acute toxicity tests, mutagenicity tests, and chromosomal aberration tests.
In the thirteen-week repeated dose toxicity study, ornithine is administered to laboratory animals over an extended period and changes in body weight, blood test values, effects on organs, and such are observed in detail. In acute toxicity tests, effects from single administration of high doses are evaluated. Mutagenicity tests and chromosomal aberration tests are tests to confirm the absence of effects on genes.
Excessive intake tests in humans have also been conducted. Healthy adults consumed quantities greatly exceeding the normal recommended amount, and safety was confirmed. Furthermore, through multiple human clinical trials, ornithine's health benefits and safety have been scientifically demonstrated. These test results have been published as peer-reviewed scientific papers and verified by researchers worldwide.
More noteworthy still is that ornithine also has a track record as a pharmaceutical. It has been used as a pharmaceutical for more than twenty years in Europe and also in South Korea, China, India, and other countries. To be approved as a pharmaceutical requires proof of safety and efficacy more rigorous than for health foods. This track record substantiates ornithine's global reliability.
Within Japan as well, Kyowa Hakko Bio's ornithine has been notified as a Food with Function Claims, and functionalities such as 'supporting liver health' and 'improving sleep quality' have been recognised. Whilst notification for Foods with Function Claims requires presentation of scientific evidence, the company's abundant research data has made this possible.
3.4 Uniquely Japanese Attention to 'Ease of Consumption'
Kyowa Hakko Bio's ornithine embodies not merely technology but characteristically Japanese meticulous consideration. Even if high-quality components are produced, unless consumers continue taking them daily, health benefits will not be realised. Therefore, the company approached product design from the perspective of 'ease of consumption'.
Tablets made through a patented manufacturing method (Patent No. 5014115) represent one result of this. The tablet shape is designed with gentle edges that do not catch in the throat. By adopting an oval shape with a smooth surface, differing from typical circular tablets, stress when swallowing is reduced.
Tablet size is also an important element. The setting of six tablets per day represents the minimum number of tablets through which the necessary amount of ornithine can be consumed. Amongst overseas-made supplements, products requiring consumption of ten or more tablets daily are not uncommon. When tablet numbers are high, the act of taking them itself becomes burdensome and continuation rates decline. Kyowa Hakko Bio, through high-concentration technology, has achieved consumption with few tablets.
Being tasteless and odourless is also an innovation that enhances continuity. Amino acids possess characteristic bitterness and odour. Through coating technology these are completely sealed in, preventing unpleasant taste or odour from being perceived in the mouth. This is consideration to prevent situations where people stop taking products because taste or odour concerns them.
This obsession with 'ease of consumption' is characteristic of Japanese companies. Whereas many overseas-made supplements are large and difficult to swallow, Japanese-made products incorporate innovations throughout 'so that people will continue daily'. This reflects the philosophy of Japanese manufacturing: designing not merely product functionality but the user's entire experience.
Kyowa Hakko Bio's case demonstrates the importance of long-term technology investment. Fermentation technology refined over a span of sixty years, accumulation of vast safety data, and product design considering consumer continuity. When all of these are combined, products with competitiveness in the global market are born.
Chapter Four: Kashu Biochem's 'Porcine Placenta Extract' − High Concentration Born from Proprietary HCP Method Technology
4.1 Challenges in the Placenta Raw Material Market
The Healthcare Business Division of Kashu Kogyo Co., Ltd. (KASYU Biochem Division), based in Kitakyushu, Fukuoka Prefecture, manufactures high-quality 'porcine placenta extract' using only full-term placentas from Japanese pigs, and has earned high praise in the beauty and OEM sectors. Through the company's proprietary high-concentration extraction technology (HCP method), it markets 'Virgin Placenta®', which retains active ingredients to the maximum extent.
Placenta (placental extract) is popular worldwide as a component supporting beauty and health. Placentas are rich in nutrients for nurturing life, including growth factors, amino acids, vitamins, and minerals, and are expected to provide effects maintaining youthful skin and recovering from fatigue. Demand is particularly high in Asian markets, where in China and Taiwan the extract has become established as a premium beauty supplement.
However, considerable variation exists in raw material quality, and many companies have struggled with quality control. Because placenta is a raw material of biological origin, quality varies greatly according to extraction method and raw material freshness.
Common placenta extraction methods each had major problems. The enzymatic hydrolysis method is an approach that decomposes placental tissue through the action of enzymes to extract the essence. Whilst extraction efficiency is good, because enzymes decompose even functional proteins, effects originally anticipated may be impaired. The freeze-thaw method is an approach that breaks down cell walls by freezing and thawing placentas to extract the essence. Whilst functionality can be preserved, the extraction rate is low at 20 to 30 per cent, yielding only small quantities of extract from large amounts of raw material.
A more serious problem was the difficulty of managing raw material freshness. Placentas begin deteriorating rapidly immediately after birth. When freshness declines, active ingredients decrease and odour also intensifies. However, if transportation time from production areas to manufacturing facilities is long, maintaining freshness is difficult. Moreover, unclear concentration labelling across the industry was also problematic. Even when products proclaimed 'high concentration', standards were ambiguous, and situations existed where consumers and buyers could not judge true quality.
4.2 Innovation Through Proprietary 'HCP Method' Technology
Kashu Biochem Co., Ltd. (Kitakyushu, Fukuoka Prefecture) developed proprietary technology called the 'HCP method (High Concentration Cell Fluid Purification Method)' to solve these challenges. The HCP method is a proprietary extraction technology the company established through more than ten years of research and development.
The greatest characteristic of this technology is its ability to achieve both high extraction rates and high concentration whilst preserving the bioactivity of functional proteins and peptides. It neither destroys active ingredients as conventional enzymatic hydrolysis methods do, nor results in low extraction rates as freeze-thaw methods do. Through proprietary physical processing and temperature control, extract is efficiently removed from cells.
Processing without applying excess heat is also an important point. Proteins are sensitive to heat and lose function through denaturation when processed at high temperatures. In the HCP method, temperature is strictly managed at each stage, maintaining nutritional value to the maximum extent. This temperature management know-how has been accumulated through years of trial and error.
Obtaining high-quality extract with little odour is also a major advantage of the HCP method. The distinctive placenta odour was a factor many consumers avoided. The HCP method effectively removes impurities that cause odour, achieving extract that is easy to consume.
Through this technology, Kashu Biochem's placenta extract conforms to quasi-drug raw material standards and is valued as high-quality raw material usable in both cosmetics and foods. Quasi-drug raw material standards are more stringent than those for cosmetics, and clearance of these standards is proof demonstrating quality's excellence.
4.3 Commitment to Traceability
Kashu Biochem uses only carefully selected domestically produced (Kyushu-produced) raw materials. For placenta quality, nothing is more important than raw material freshness and origin. The company has established a system using only fresh placentas from contract farms.
Contract farms are carefully selected facilities where rearing environments and hygiene management are thorough. Everything is checked in detail: the health condition of pigs, feed content, antibiotic usage status, and such. Without placentas obtained from healthy mother pigs, high-quality extract cannot be produced.
When fresh placentas immediately after birth are delivered from farms to factories, first the umbilical cord is carefully removed. Umbilical cords contain many blood vessels and, if left, adversely affect product quality. This work is performed manually by skilled workers. Next, only high-quality placentas are selected. Colour, shape, size, and such are visually confirmed, and only those meeting standards proceed to processing.
In-house integrated management of processing from raw materials to extract in the company's own factories (Hiroshima and Fukuoka Prefectures) is also key to quality assurance. When outsourcing to external parties, inevitably portions arise where quality control oversight does not reach. By managing everything in-house consistently, all processes are understood and, should problems arise, immediate response is possible. Complete traceability is ensured, with everything recorded: which lot was made when and from raw materials from which farm.
This thorough traceability represents major reassurance for overseas buyers. Particularly in the Chinese market, because various food safety problems have occurred in the past, consumers are extremely concerned about raw material origins. Being able to clearly indicate information such as 'raw materials from specific Japanese farms' becomes a powerful marketing weapon.
4.4 Industry-Leading Cleanrooms
Kashu Biochem's manufacturing facilities are equipped with Class 100 to 100,000 cleanrooms. Cleanroom class is determined by the number of particles 0.5 micrometres or larger contained in one cubic foot (approximately 28 litres) of air. Class 100 represents an extremely clean environment where these particles number one hundred or fewer. This is a cleanliness level comparable to pharmaceutical manufacturing.
Placenta-like raw materials of biological origin are materials with high risk of microbial contamination. Even slight bacterial contamination can render entire products unusable. Advanced cleanrooms are investments to minimise this risk. Within cleanrooms, air is constantly filtered, whilst temperature and humidity are also strictly controlled. Workers wear clean suits covering their entire bodies and pass through air showers before entering.
More noteworthy still is that manufacturing equipment such as filters and constant temperature chambers is designed and manufactured by the company's own engineering division. Commercially available general-purpose equipment is not optimised for placenta characteristics. By employing engineers in-house, the company develops equipment that can achieve temperature ranges, pressures, and processing times optimal for placenta. Through this in-house production, fine adjustments to manufacturing processes can be performed swiftly, enabling constant pursuit of the highest quality.
Kashu Biochem is a small or medium-sized enterprise with approximately fifty employees. It does not possess the abundant financial resources of large corporations. However, by differentiating through proprietary technology and maintaining a craftsman-like commitment to quality, it provides value different from major companies. Flexible customisation response is also a strength unique to small and medium-sized enterprises. According to customer requirements, concentration and form can be adjusted, or specific components can be enhanced.