Why 'Visibly Clean' Isn’t Always Safe in Pharma Facilities: The Bioguard Advantage
When clean isn’t safe enough
In the pharmaceutical manufacturing industry, surface cleanliness often deceives. A manufacturing facility may appear spotless yet still harbour microbial contamination, risking product safety and compliance.
In environments handling Active Pharmaceutical Ingredients (APIs), even invisible residues can cause serious problems, including risk of cross-contamination and batch failures.
Today, regulatory bodies emphasize that sanitisation and disinfection in pharmaceutical industry must go beyond visible residue limits — it must be scientifically validated and microbiologically safe.
Regulatory shifts raising the bar
The demand for higher sanitisation standards in pharmaceutical manufacturing is growing rapidly. The Indian Pharmacopoeia Commission (IPC) has proposed guidelines for disinfectants, expected in 2026, to formalize how sanitisation must be validated within manufacturing facilities.
Simultaneously, frameworks like Good Manufacturing Practices (GMP) and ISO 1061:2017 standards require cleaning procedures that eliminate both visible residues and hidden contamination risks.
Concerning trends are pushing urgency:
- Over 1,394 drug batches recalled in 2023–24 due to quality issues, up from 950 previously.
- 500+ inspections conducted since 2022 by the CDSCO focusing on sanitisation practices, disinfection, and cleaning validations.
In today’s risk-based approaches, it’s clear: sanitisation and disinfection in pharmaceutical industry must prioritize validated microbial safety, not just visual detection.
Why visual cleanliness is not enough
Visual inspection remains a necessary step in verifying clean equipment and surfaces, but it cannot guarantee microbiological safety.
Even with good lighting sources and proper visual detection techniques; biofilms, spores, and invisible chemical residues can persist on process equipment, surfaces and in critical areas.
Contaminants like Pseudomonas aeruginosa, Candida albicans, and Geobacillus stearothermophilus can survive normal cleaning and disinfection procedures and hide in inaccessible areas of poorly designed equipment.
Without scientifically validated sanitisation methods, the cleaning process remains incomplete — increasing the risk of cross contamination across the pharmaceutical manufacturing lifecycle.
The risks of generic disinfectants
Many cleaning, surfactants and disinfection agents used in manufacturing facilities are ineffective for modern sanitisation and disinfection demands. Generic disinfectants often:
- Fail to meet sanitisation requirements under Good Manufacturing Practice (GMP) standards
- Leave behind visible residues or toxic byproducts that interfere with APIs
- Require higher dilution, combination of cleaning and disinfection agents or excessive drying times, disrupting production schedules.
- Lack validation for critical environments, studies on dirty conditions and clean equipment standards.
Continuing with traditional, non-validated cleaning procedures exposes manufacturers to audit failures, contamination risks, and costly recalls.
The Bioguard advantage: Redefining sanitisation standards
Bioguard, developed and manufactured in the UK under ISO 9001:2015 and GMP-compliant processes, is redefining sanitisation and disinfection in pharmaceutical industry through scientifically validated cleaning products.
Unlike generic products that rely on aldehydes, alcohol or outdated QAC formulations, Bioguard is designed with 7th gen QAC-based disinfectants , offering superior performance without the associated risks.
What makes Bioguard unique:
- Combined dual-action of cleaning and disinfection: Reduces downtime and simplifies cleaning and disinfection processes.
- Proven sporicidal action: Eliminates both bacterial and fungal spores efficiently by >log3 reduction.
- Validated compliance: Meets USP Chapter 1072, EN16615, and EDQM-accredited plant standards.
- Fast efficacy: Disinfects surfaces within 30 seconds, enhancing operational productivity.
- Safe formulations: VOC-free, biodegradable, and safe for equipment design materials like stainless steel, PVC, glass, acrylic HDPE etc
- Gentle on staff: Dermatologically tested, suitable for frequent use with nitrile and latex gloves.
Bioguard ensures that sanitisation and disinfection cover the needs of modern pharmaceutical manufacturing — protecting both the product and the process equipment integrity.
The impact of smarter sanitisation and disinfection
Facilities adopting validated cleaning procedures like Bioguard's solutions have achieved:
- Faster cleaning validations
- Reduced downtime across manufacturing operations.
- Improved visual inspection outcomes with minimal visible residues.
- Enhanced readiness for risk-based regulatory audits.
- Lower usage of harsh cleaning chemicals.
In every manufacturing facility, from critical aseptic areas to storage zones, comprehensive Sanitisation and disinfection in Pharmaceutical Industry directly correlates to operational success and patient safety.
Conclusion: True cleanliness goes beyond sight
In today's pharmaceutical manufacturing environment, "visibly clean" is no longer the benchmark. True compliance demands validated sanitisation and disinfection procedures, microbiological assurance, and full regulatory readiness.
Choosing advanced sanitisation and disinfection solutions like Bioguard ensures manufacturing facilities meet the evolving standards for clean equipment, minimized contamination risks, and long-term GMP compliance.
Bioguard: Setting new standards for Sanitisation and disinfection in Pharmaceutical Industry — because clean isn’t enough when lives are at stake.
Citation’s
USP (United States Pharmacopeia) 41 - Chapter 1072:
United States Pharmacopeia. USP 41 - Chapter 1072: Cleaning and Disinfection of Pharmaceutical Facilities. United States Pharmacopeial Convention, 2020, www.usp.org.
EN 16615:2015:
European Committee for Standardization. EN 16615:2015 – Cleanroom and Controlled Environments - Cleaning and Disinfection of Surfaces. CEN, 2015, www.cen.eu
FDA Regulations:
U.S. Food and Drug Administration. Good Manufacturing Practice (GMP) Guidelines. FDA, 2020, www.fda.gov.
Research papers on microbial contamination in cleanrooms:
- M. C. Thomas, et al. “Microbial Contamination and Biofilms in Pharmaceutical Cleanrooms.” Applied and Environmental Microbiology, vol. 85, no. 8, 2019, doi:10.1128/AEM.00100-19.
- R. G. Seitz, et al. “Contamination Risks and Cleaning Strategies in Pharmaceutical Settings.” Journal of Pharmaceutical Sciences, vol. 108, no. 10, 2019, pp. 3021-3034, doi:10.1016/j.xphs.2019.08.007.
Regulatory Bodies:
European Medicines Agency. Guidelines for Cleaning and Disinfection in Pharmaceutical Manufacturing. EMA, 2019, www.ema.europa.eu
Central Drugs Standard Control Organization. Guidelines on Cleanroom Standards for Pharmaceutical Production. CDSCO, 2020,www.cdsco.gov.in.
