Common mistakes in pharma equipment disinfection and how to avoid them

Common mistakes in pharma equipment disinfection and how to avoid them

Overview

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  • Source: BIOGUARD

  • Date: 09 Nov,2025

A few months back, a leading Indian pharmaceutical company lost an entire production batch, bearing almost a ₹20 crore loss. The culprit was a tiny trace of residue on a mixing blade. No formulation error. No equipment failure. Just inadequate disinfection. These stories don’t make headlines, but they’re far more common than the industry likes to admit. In pharmaceutical manufacturing, disinfection isn’t just another line in your SOP manual. It’s a key to achieve successful audit (without a warning letter). That’s a way to ensure product safety and avoid costly recall and regulatory scrutiny.

Yet even facilities with cutting-edge infrastructure make surprisingly basic mistakes when it comes to cleaning and disinfection protocols. Here’s what goes wrong most often — and what you can do about it.

Picking the Wrong Disinfectant

Walk into any pharma facility and you’ll find multiple disinfectants in use. Some chosen for their power. Others for their speed.

But here’s the problem: alcohol-based products evaporate before they can properly disinfect. They’re useless against spores. Peracetic acid and chlorine might kill everything in sight, but they’ll also eat through your equipment and fill your production area with harsh fumes.

What you need is something that ticks all the boxes: broad-spectrum efficacy, validated to pharma standards (USP <1072>, EN norms), and safe for the surfaces you use it on. Bioguard’s formulations do exactly that. The Ready-to-Use and Concentrate products work across bacteria, fungi, spores, and viruses without damaging stainless steel, glass, or polymer surfaces. They’re designed specifically for EDQM-accredited plants and full GMP compliance.

Skipping the Cleaning Step

Disinfectants can’t work alone. On unclean surfaces, powder residue, biofilm, or organic matter creates a protective barrier that microbes hide behind. But adding a separate pre-cleaning step isn’t cheap. A mid-sized plant spends ₹25–50 lakhs annually just on additional cleaning chemicals. Factor in validation, SOPs, and training, and compliance costs jump by 10–15%.

The real damage? Downtime. Two-step cleaning adds 15–18% to equipment idle time—costing crores in lost production each year. Every hour a filling line waits for clearance is revenue lost, batch after unutilized batch.

This is where dual-action products make sense. Bioguard’s Concentrate and Ready-to-Use formulations clean and disinfect in one go. One product. One validation. One training module. Equipment gets back to production faster, and the savings show up immediately on the profit & loss statement.

Ignoring proper contact time and dilution

Disinfection requires patience. Wiping surfaces down too quickly leaves microbes behind. Using the wrong dilution ratio either wastes product or renders it ineffective. We’ve seen operators rush through contact times because production is breathing down their necks and facilities using dilutions that haven’t been validated for their specific bioburden.

Bioguard Concentrate delivers >log 5 reduction for both bacteria and fungi in just 30 seconds. For spores—often the toughest challenge in pharma—5 minutes of contact time achieves the same >log 5 reduction. All of this works even at high dilution ratios, maintaining sterility without slowing down production.

Mixing incompatible chemicals

Mixing disinfectants. Adding fragrances. Using different products in rotation “to prevent resistance.”

These practices sound reasonable until you realize they can neutralize efficacy or create hazardous reactions. There are many instances where operators were combining products because no one told them not to.

Solution: Use one validated product line across your facility:

Bioguard Concentrate

Multi-surface disinfectant that works at low dilution rates. Handles both routine cleaning and high-risk zones.

Bioguard Ready-to-Use

Grab-and-go spray bottles for immediate equipment and surface disinfection. No mixing required.

Bioguard Hand Foam

Alcohol-free, EN1500-tested, skin-safe hygiene that lasts 10x longer than standard hand gels.

Bioguard Wipes

Single-step cleaning and disinfection for tools and contact surfaces. Leaves no lint or residue.

Bioguard Absorb Powder

Turns liquid spills into solid gel in under a minute. Absorbs up to 300 times its weight. Perfect for containing growth media, chemical, or disinfectant spills in production areas.

When everything in your facility comes from the same product line, you eliminate compatibility issues, reduce training complexity, and maintain consistent performance.

Sticking with Outdated Formulations

Some facilities still use disinfectants containing NDMS (nitroso dimethylamine), aldehydes like formaldehyde and glutaraldehyde, or other compounds that no longer meet EU Maximum Residue Limits. Maybe the product was validated years ago and no one’s questioned it since. Maybe it’s just cheaper.

But regulatory standards evolve. What passed muster five years ago might not fly in your next audit.

Bioguard’s products are NDMS-free and biodegradable.

They align with current EU guidelines while meeting EDQM and GMP standards. You get regulatory compliance and environmental responsibility in the same package.

Ignoring Hard-to-Reach Spots (Until There’s a Problem)

Valves, filters and equipment crevices collect residue and harbour microbes, but they’re easy to overlook during routine cleaning.

Without proper environmental monitoring, contamination builds up silently until it shows up in your microbial sampling or — worse — in a failed batch.

Bioguard disinfectants are tested in real-world dirty conditions, not just pristine lab settings. They’re validated for complex equipment geometries. Pair that with regular swab testing and risk-based sampling, and you’ve got traceable, effective cleaning cycles even in difficult areas.

Why BIOCHEM® Technology Works Better

Most disinfectants force you to choose strong but harsh, or gentle but slow. BIOCHEM® — the technology behind Bioguard products — doesn’t make you compromise.

Let’s be honest about what’s out there:

  1. Alcohol-based products evaporate too fast and create fire hazards, not effective against some microorganisms & spores, will not work in dirty environments without pre cleaning.
  2. Hydrogen peroxide corrodes metals and irritates skin, can easily be deactivated if incorrectly mixed, not used quickly or in presence of high levels of dirt.
  3. Peracetic acid damages sensitive equipment with its strong odour, can be deactivated if incorrectly mixed or not used quickly.
  4. Chlorine loses effectiveness in the presence of organic matter and has a short life span.
  5. Aldehydes are toxic, leave residues, and pose major health risks.
  6. Phenolics aren’t safe for product-contact surfaces and create health risks.
  7. Biguanides offer limited coverage and act slowly.

BIOCHEM® combines quaternary ammonium compounds with surfactants and emollients to deliver:

  1. Broad-spectrum kill in 30 seconds
  2. Dermatologically tested, pH-neutral, alcohol-free formula
  3. No corrosion & no harsh odours
  4. Dual cleaning-disinfection action – lowers down time

You can use it on everything from tablet coating machines and liquid filling lines to lab benches and HVAC components without worrying about equipment damage or operator safety.

Where You Can Use Bioguard Products:

  1. Laboratory glassware, laminar, CO₂ incubators, water trays
  2. Mixing vessels, dryers, granulators, coating pans
  3. Filling machines and packaging equipment
  4. Cleanroom walls, floors, and HVAC components

Conclusion

In pharma-production plants, disinfection mistakes hide in corners, build up slowly, and reveal themselves at the worst possible moment — during an audit, in a failed batch, or in a regulatory warning letter.

Given the status and magnitude of India’s pharma sector, companies can’t afford to treat cleaning as just another checklist item. It’s quality assurance that protects the products, the people, and our reputation.

Choosing the right disinfectant isn’t about finding the cheapest option or sticking with what you’ve always used. But with Bioguard, you get all three: uncompromised sterility, seamless production continuity, and peace of mind to run the pharma company to its fullest capacity.

References:

  1. USP<1072>
  2. Types of disinfectants
  3. Best practice – Pharma facility sanitisation
  4. Biochem®
  5. Alcohol inefficacy on bacteria
  6. Indian pharmaceutical company lost a batch
  7. Recall cost analysis
  8. Pharma machines

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