Identifying the Optimum Disinfectant to Deliver Business Critical Enhancements

Diversey Food & Beverage
Monday, April 16, 2018

Cleaning and disinfection of surfaces are fundamental to maintaining the cleanliness of pharmaceutical manufacturing operations. Regulators demand it, and customers are becoming progressively more investigative in the standards they expect from suppliers.

While most pharma facilities fully appreciate the role disinfectants play in ensuring sterile environments remain sterile, far fewer are aware of how to select the best disinfectant for the role it will perform.  Substantial efficiencies and resource savings can be delivered by ensuring an as-close-to-perfect disinfectant is in use.  

The art of disinfectant selection

There are some significant barriers to identifying the correct disinfectant. Firstly, the contaminants that pharma facilities have to account for and mitigate are wide-ranging, and efficacy of disinfectants must be assured, which can lead to an unnecessarily powerful solution being deployed. There are cost and environmental concerns if this happens.

The range of contaminants in sterile facilities includes macroscopic contaminants (packaging for example), production residues, chemicals (dirty gloves, maintenance chemicals, hygiene product residues), particles and microorganisms.

There is no such thing as a “perfect” disinfectant. Disinfectant selection always involves trade-offs in actual performance versus ideal performance. But, efficacy against the significant list of contaminants is the cornerstone of compliance. The disinfectant must kills what’s important, kill it quickly, before surfaces air dry and it must not be affected by environmental factors such as soils and temperature. It must also be persistent across a long period of time, and powerful enough to remove bioburden.

The second barrier to identifying the perfect disinfectant is that the solution must be safe to use in the environment for which it is required. The solution must of course be non-toxic, compatible with surfaces to prevent unnecessary environmental damage and non-flammable.

Thirdly, convenience is also paramount, with disinfectants tending to be used at the end of a shift or at product changeover, lost time can lead to reduced profitability. Speed is of the essence so the product must be easy to use too.

All of these considerations require balance and cross-referencing. The art of disinfectant selection is to find the sweet spot between each of these factors, whilst being as cost-effective, resource-light and efficient as possible.

Taking on the regulatory and compliance challenge

There is also the burden of proof faced by pharma companies to consider. Facilities are expected to be able to demonstrate conclusively that their disinfectants of choice are effective under the conditions in which they are used. This is true of regulators and customers. There needs to be an evidence trail showing a reasoned and justified approach to disinfectant studies.

The Eudralex (the body of European Union legislation in the pharmaceutical sector) Guide to Good Manufacturing Practice specifies that when in use, disinfectants should be used rotationally, must be sterile prior to use in class A and B environments and must be manufactured to GMP standards. The rotational regime should be decided on historical data and the results of efficacy studies, and coupled with on-going trend micro data. It also needs to account for corrosion, health and safety issues, cost and residue.

Shifting governance and regulatory attention, such as REACH and BPR, has added to the challenges of preventing and controlling contamination. Cleaning validation has key prerequisites, namely selecting suitable cleaning agents, such as disinfectants, and determining justifiable cleaning process parameters. Validation by global headquarters for regional sites is also required by some pharmaceutical businesses. Proper selection of disinfectants could simplify cleaning validation efforts significantly. 

Pharmaceutical operations tend to have a standard operating procedure for cleaning, but some of the processes can be slow-going and damaging to productivity, so considering how the disinfectant will be used within is as crucial as identifying the best solution. Selecting the perfect disinfectant to use in each individual circumstance can take an inordinate amount of time. Trial and error can also result in a large amount of operational downtime, and be costly for the entire facility operations.

As is clear, there are significant and wide-ranging stress factors to consider in selecting a disinfectant. For over 20 years, Diversey have been developing innovative hygiene solutions for sterile and non-sterile production. The technical centre is able to select from a complete chemical portfolio, Diversey ClearklensTM. Supply from the portfolio is guaranteed for five years, with nor changes to formulas or specifications unless with at least six months’ notice.

Accounting for the universal impact

It is crucial that in selecting the disinfectant, all of the stress factors and variables are considered as part of a holistic process. There are efficiencies to be found in the attributes of the disinfectant itself, and in how it is used.

Process optimisation depends on efficient, effective cleaning of difficult and stubborn soils, specific for the pharma and cosmetic industry.  Diversey Cleaning-in-Place (CIP) systems can be incorporated into all the equipment for the pharmaceutical industry. Automating cleaning and disinfectant use and applying the unique Diversey vision and know- how ensures repeatability, allows validation, minimises downtime and ensures a sustainable approach.

What disinfectant is the best fit depends largely on the properties most important to you. Other characteristics that may be considered include sustainability, efficacy against specific pathogens and easy test methods to verify activity level of a solution.

Defining and implementing the most effective disinfectant selection and application programme for pharmaceutical facilities can be a pain-staking process, but one that can pay significant dividends if it is considered and addressed robustly.

 

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