Microbial Contamination AND HOW TO COMBAT IT

Why you should be using a monitoring program, and how nomad can help

 

MICROBIAL CONTAMINATION TESTING – A NEW APPROACH

Testing for regulatory compliance used to be simple – everything was clearly defined and specified: the facility to use, staff, equipment, protocols, sampling plan, the frequency and the what constituted an acceptable result. You could basically hand over the required number of samples to the appropriate environmental testing lab, and if your results were within the limits, you were good to go.

That approach, however, is now known to not provide the best results in terms of consumer safety. Some of the documented reasons include:
  • Tests required for regulatory compliance are expensive so businesses tend to do the minimum safety testing required. This minimum is too low to ensure good process monitoring.
  • Each process, product, product use and facility is unique: a one-size-fits-all approach has its limits.
  • Lifestyles, consumer habits and consumer demands change quickly. Regulations are slow to catch up.
Photo of a women holding a pen and a folder
Photos of someone washing their hands

HACCP – MOVING TOWARDS PREVENTION AND MONITORING

Nowadays, more emphasis is placed on self-regulation, prevention (HACCP) and maintaining hygiene throughout the supply chain. Industry is taking a bigger and bigger role in consumer safety and satisfaction.


HACCP and other bio-hazard risk management methods require businesses to assemble a multidisciplinary team and conduct step by step analysis to design and implement a monitoring program that works for them. HACCP is widely recognised as an efficient and cost effective way of controlling physical, chemical and biological hazards and it's a good idea whenever necessary for regulatory, operational or strategic reasons. Good Hygienic Practices (GHPs) also contribute greatly to consumer security and product quality. Controlling the microbial aspects of a process contributes to increased efficiency and reputation.


With few exceptions, these principles or approaches do not contain absolute values for an acceptable microbial counts. In many instances the acceptable counts will be determined by experience from your own data.


At Pinqkerton, our objective is to help you build that data.

The Value of BioBURDEN, HyGiene AND ENVIRONMENTAL testing


When implementing an environmental testing program, the main goal is to build up a powerful historical database of your microbial counts, enabling you to detect issues as soon as they arise, and remedy them quickly and effectively.


Among other benefits, your data will allow you to:

  • Measure the effectiveness of sanitary design, staff practices and operational methods
  • Glean information about indicator organisms, spoilage organisms and/or pathogens of concern, so that you can take the appropriate measures to prevent potential outbreaks
  • Obtain early warning of microbiological hazards in production and post-production environments
  • Identify microbial growth niches and hot-spots that might act as a source of contamination
  • Document overall sanitation state of the facility
  • Verify the results of the sanitation program and determine required frequency for cleaning and sanitation

WHY RUN a HYGIENE testing program?


Hygiene monitoring is part of an effective environmental monitoring program. The goal of hygiene monitoring is to verify that your cleaning and sanitation procedures are effective and to alert you to potential problems as and when they arise.

Your cleaning procedures are vital to the smooth running of your processes, as well as to the safety of your customers and the quality of your products. Just as you would monitor machinery or equipment to ensure it is performing correctly, you should monitor your cleaning regimen for effectiveness and potential problems.


Sources of contamination


Contamination is introduced into the manufacturing environment through:
• Raw materials
• Pests
• Air
• Water
• Employees

It is dispersed within the facility through
• Direct and indirect contact
• Water
• Air

It will develop/colonise if are present :
• Water (although some will survive without water)
• Nutrients (although some will grow on almost nothing and survive starvation)
• Ambient temperature: (although some develop at 4°C, others resist high temperatures)

And be located:
• Low points in water lines, tanks, equipment, rooms – contamination will sink when it can
• In presence of water: production water, waste water, organic material, humidity, condensation
• Still areas: dead-ends in distribution systems, equipment with extended turn-around time, oversized reservoirs
• In areas protected from sanitation: hard-to-clean areas (cracks, porous material, biofilms, surfaces above water level in reservoir, ..), weakness in preventive measures (colder parts of heating system, warmer parts of a refrigerating system, lowest exposure to sanitants)

WHAT FACTORS CAN INCREASE MICROBIAL CONTAMINATION RISK?

  • Staff:
    - Lack of training
    - Direct contact between operator's hands and materials
    - Malpractice

  • Buildings and Facility:

    - Inadequate pest control

    - Rough floors, walls and ceilings

    - Material and staff flow

  • Equipment:

    - Inappropriate design, size, material

    - Improper cleaning and sanitation

  • Raw Materials:

    - Contaminated when entering the facility

    - Improper sampling, testing and use of materials that fail to meet acceptance specifications.

    - Poor storage conditions such as heat, cold, sunlight, moisture, etc.

  • Manufacturing Process:

    - Lack of dedicated production area, inappropriate zoning
    - Inappropriate cleaning in-between batches
    - Manufacturing system exposing the product to the immediate environment

  • Air Processing System:

    - Accumulation of organic material in or near HVAC (Heating, Ventilation and Air Conditioning) air intakes

    - Ineffective air processing

    - Condensation

If you would like help with managing risk factors in your business using a monitoring program, feel free to contact us.

WANT ADVICE ON SETTING UP A MICROBIAL TESTING PROGRAM WITH NOMAD?

We'd love to hear from you to answer any questions you might have!

COST OF OWNERSHIP and RETURN ON INVESTMENT


In any business, ROI is an important component of any change plan and a microbial monitoring program is no exception.


The productivity gains and reduction in Cost-of-Non-Quality (CONQ) which will result from the new monitoring plan should be offset against the cost of design and  implementation. Calculating CONQ is not always straightforward. If, for example, your goal is to avoid batch losses or to reduce testing costs by testing internally, the calculations might be fairly simply. However in cases where the CONQ is not immediately tangible, it can be tricky to evaluate the ROI of an internal monitoring program. For example, how highly do you value the reputation improvement that might come from a high standard of internal quality and safety and from avoiding errors? These are questions that only you can answer for your business.


It can equally be tricky to assess the costs of implementing a microbial monitoring program using nomad testers. Although all of our prices are transparent and available on our website, it would be overly simplistic to limit costing to the price of the consumable testers. Your own accounting methods, staff allocations and internal processes will influence your estimate of the overall budget that a monitoring program will require.


At Pinqkerton we are confident that we provide great value for money in our testing kits, and hope that our products will enable you to implement a cost-effective monitoring program with limited start-up costs.


Check out our Purchasing Guide for nomad Testers and kits for more information regarding pricing.


Table comparing the costs of nomad and the use of other lab

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