North America to be the Torchbearer to Cleanroom Disinfectant Market
Large-scale investments for installation of pharmaceutical manufacturing units in North American countries such as Mexico will continue to drive the demand for cleanroom disinfectants. The importance of cleanroom disinfectants in monitoring and controlling the extent of contamination from airborne particles, dust, water vapor, microbes, and chemical vapor is a central growth driver for market players.
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Selection of Effective Disinfectants
Selecting cleanroom disinfectants is the key to successful sterilization of products and production units. If the disinfectant is not suitable for the environment, any degree of sophistication in disinfectant processes will be ineffective. Disinfectants are chemical compounds that mitigate the presence of harmful microbes. The versatile nature of disinfectants in the activity spectrum, efficiency, and modes of action makes it crucial for carefully selecting the disinfectant for a particular use-case.
Careful inspection of the applicant environment, taking stock of outside factors such as labor hygiene, and all possible modes of entry of pollutants are basic steps in selecting an ideal disinfectant. A minimum of two disinfectants are required to cover all contamination possibilities. One for the general environment such as floors, and vents, and another for utensils and production lines. The EN1276 – Chemical Disinfectants Bacterial Activity Test is a popular standard followed by technicians while selecting the ideal disinfectant for factories, laboratories, and healthcare facilities.
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Cleanroom Disinfectant Rotation Guidelines
It is crucial to examine and employ effective root-cause investigations for ensuring 100% disinfection. Scant methods can cause significant health risks for patients, medical staff, and it might also lead to product recalls resulting in financial losses for pharmaceutical companies. Rotation of disinfectants is another popular method of ensuring the efficiency and effectiveness of cleanroom disinfectants. By rotating core disinfectants, manufacturers and medical facilities can ensure that pollutants do not develop resistance to disinfectants employed. Based on the region of operations, the regulatory recommendations pertaining to cleanroom disinfectant rotation are as follows:
Japan Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing – Necessary screening and classification of bacterial isolates in each manufacturing environment. Prior and periodical validation of disinfectants in their appropriateness and reliability of removing contaminants. Efficacy of the chosen disinfectant must be weighed against the type and count of microorganisms identified during periodic environment monitoring. Suitable sporicides and fungicides must be deployed upon detection of spore forming bacteria or fungi.
United States Food and Drug Administration (US FDA) guidelines on aseptic Manufacturing- Selection of disinfectants based on the microbial vegetative flora found in the facility. Based on environment data, sporicides must be used in regular time intervals to avoid spore formation in the facility. Microorganisms associated with severe contamination must be investigated thoroughly and accounted for by the disinfectant in rotation.
Brazil National Health Surveillance Agency (ANVISA) resolution – RDC n.17 Article 315: Regular sanitation of clean areas is crucial for manufacturing of sterile products. The cleanroom disinfectant programs must be approved by a quality analyst. Regular monitoring of manufacturing units to identify resistant microorganisms is necessary. Cleanroom disinfectant rotation schedules must take into account environmental factors and production capacity.
European Medicines Agency (EMA) EudraLex Annex 1-Clean areas must be disinfected regularly based on a schedule that regards factors such as development of resistance in contaminants. More than one type of disinfectant must be used to ensure effective cleaning. Rotation schedules must account for the development of resistant strains.
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COVID-19 Impact on Cleanroom Disinfectants
It is of utmost importance in the current scenario that cleanroom disinfectant practices are adopted by healthcare institutions of all sizes. COVID-19 is an infectious disease which spreads with physical contact or transfer of bacteria from one patient to another. This can also happen if the medical staff or the patient touches the belongings of a COVID-19 infected patient. It has thus become crucial that effective cleanroom disinfectant strategies are applied in healthcare institutions during the pandemic. Manufacturers of disinfectant hence find remunerative opportunities in healthcare applications of cleanroom disinfectants. The increasing number of cases of COVID-19 also increases the demand from residential applications.
As consumers look to ensure 100% protection from the novel coronavirus, market players will witness a surge in demand from residential applications. Further, the rampant increase in the number of patients suffering from this life-threatening disease warrants the utilization of cleanroom disinfectant on a regular basis. To stop the spread of COVID-19, governments are also spending on sterilizing public infrastructure places.
Essential manufacturing units such as pharmaceuticals, and food & beverages are directed by governments to deploy stringent cleanroom disinfection policies. The cleanroom disinfectant market will witness a healthy growth trajectory on the back of sterilization needs owing to COVID-19. Hand sanitizers are expected to lead demand generation owing to ubiquitous applications across industries and consumer groups.
Global Cleanroom Disinfectant Market Segmentation
Non-oxidizing (alcoholic, phenolic, quaternary ammonium compounds, and others)
Oxidizing (halogens, oxidising agents, chemical containing oxygen deposits, and others)
By Mode of Action
Cell Wall Targeting
Cytoplasmic Membrane Targeting
Medical Device Manufacturers
Cleanroom Disinfectant Market Competition
This FMI study, in addition to highlighting the crucial role of market dynamics in the growth of the cleanroom disinfectant market amid the COVID-19 pandemic, offers information on the developments in the competitive landscape. Key players covered in the market study are, Illinois Tool Works, Inc., Thermo Fisher Scientific Inc, Berkshire Corporation, Kimberly-Clark Worldwide, Inc., Cardinal Health, Contec Inc., and Texwipe. Investments in innovative production techniques, and capacity expansion are popular strategies. Major players are leveraging superior production facilities to capitalize on the exponential increase in demand due to the COVID-19 pandemic.
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