Safety officers and management need to be constantly vigilant that their hygiene and safety measures are doing what they should, and they are keeping up with the latest techniques, technologies and products to ensure they are sustaining the most appropriate hygiene and safety levels in their companies. What’s more, with the Medicines Control Council (MCC) getting stricter with its testing, companies should not take these issues lightly. To assist, PHARMACEUTICAL & COSMETIC REVIEW takes a look at some of the latest trends in environmental hygiene management, and, hand in hand with this, ensuring the supply of ample quantities of ultrapure water to your production process.
Effective environmental hygiene management is crucial to help reduce levels of contamination in finished products, leading to improved quality, fewer batch rejections and lower risk of product recall. Sascha Rother, manager at basan group, a leading distributor of products and related services for cleanrooms, shares the lowdown on what he sees happening in the hygiene space.
He says, ‘I am excited about the new trigger spray system from Shield Medicare, a division of Ecolab, that basan distributes in South Africa. Conventional trigger sprays that are used with cleanroom disinfectants suck air back into the system, resulting not only in the contamination of the bottle contents within a few hours, but also spreading the impurity around the cleanroom as continual use of the disinfectant occurs.’
However, new development work on the company’s patented SteriShield System has resulted in a closed trigger system where air cannot enter the bottle, and is forced into a separate bag – so the contents remain sterile. While this option is not cheap, Rother says that there is no alternative available in South Africa and it has seen interest from the industry.
Rother is adamant that the industry should be wary of taking cheaper options or short cuts, which mean businesses cannot make informed decisions about which products to use and be able to trace where possible contamination comes from. ‘For instance, if you disinfect with an untested, contaminated alcohol that then leaves a residue on your surfaces: how will you easily trace this back to the source? The last place you’ll think of for the source of contamination would be your disinfectant,’ he adds.
One such example is in the use of cleanroom wipes. ‘There are so many options,’ says Rother, ‘For every possible application, companies need to narrow down their choices.’ He warns companies that there is ‘no such thing as a lint-free cloth. People think this is the case, but the reality is they can’t see the particles’.
Back to his point about testing: cleanroom wipes have to be thoroughly tested to know the level of particle that will be dropped so that the correct level of wipe can be used for the specific application.
‘Similarly with cleanroom gloves,’ he says. Some 99 per cent of the industry uses powder-free examination gloves, and for the majority that is okay. But complications arise when the gloves need to be disinfected before use. Depending on the grade of glove, the alcohol permeation time will vary and could result in the gloves needing to be changed every four to five minutes to maintain a sufficient level of protection.
Without having correctly tested gloves, how do you know how often to change them? And, at the other end of the spectrum, when dealing with, for instance psychotropic and oncology drugs, the operator needs to be protected from the drugs and the correct grade of glove needs to ensure this occurs.
basan is taking the lead in educating the industry on this space with the launch of a cleanroom conference later this year. The conference date is scheduled for early October, and will be held in conjunction with the University of Pretoria. The event will focus on education and networking as well as highlighting basic principles, sanitation guidelines, clean techniques, and good manufacturing practices and guidelines.
Selectech, which specialises in the supply of water testing, beverage and laboratory scientific testing equipment across Africa, assists companies with the monitoring of contamination with its ATP meters and swabs. These are able to detect contamination on surfaces and in water, including food residue, allergens and bacteria.
The main advantage is speed – results are available in minutes – which allow safety officers to make decisions and take corrective action immediately. While the tests detect residue, they are not a cultural microbiological test for bacteria and further tests will need to be done to work out the quantity and type of contamination.
How do the tests work? ATP (adenosine triphosphate) is the universal energy carrier that is found in all living organisms – animal, plant, bacteria, yeast and mould cells. During testing, samples are taken using swabs with a luciferase reagent. A System sure Plus Luminometer then measures the amount of light generated and provides information on the level of contamination in 15 seconds. The presence of ATP indicates the incidence of contamination and also shows a potential for support of bacterial growth.
When it comes to water purity – this goes hand-in-hand with good hygiene to produce a high quality, safe product – Selectech assists with the measurement of chlorine in water. This ensures that water used for production, cleaning and sanitation is of good quality for optimum health and safety.
According to Selectech, chlorine is the most common form of disinfectant in water, and by measuring the amount of chlorine present in a water supply you can gauge how safe the water is. It is important to calculate the correct amount of chlorine to be added – too much is negative to health and wastes money, too little can result in a high level of disease causing pathogens. Of course, safe chlorine levels depend on the application. For example, the recommended guideline for safe drinking water is 4mg/l chlorine.
DPD tablets can accurately measure chlorine levels from 0.001mg/l to 10mg/l. When a sample has a chlorine level that is higher than 10, the colour is bleached out of the chlorine tablet – there is a quick show of pink colour and then the sample returns to its original colour. Dilutions can be done to determine high range chlorine levels or Selectech supplies direct read-out high chlorine level photometers.
Echoing Rother from basan’s view, the cheap shortcuts are seldom a good idea and Selectech maintains that for regular water quality testing, a reliable instrument and reagent system will prove more economical and accurate for long-term use. The company also supplies comparator systems and photometers for accurate, reproducible results.
A specialist supplier of water filters and R/O systems, Mar Cor Purification announced earlier this year the launch of a new USP Standard Water System design, the BIPPure LSX. The product is built for the pharmaceutical, cosmetics, medical device and other high purity and bacteria controlled requirements. According to Mar Cor, unlike previous water systems that were designed for specific market segments, this is built to install quickly, incorporate energy saving technology, automated hot water sanitisation of the system, and a high level of automation to adjust operating parameters to optimise the operation.
With ongoing innovation and new product releases in the space, it is essential to revisit your hygiene and safety protocols continually, as well as equipment and consumables. This allows you to ensure they are fit for purpose and you have the best combination in use to prevent contamination, or in the event of contamination, be able to quickly trace the source and be able to remedy it.
About the author: Vanessa Clark started her career as a journalist in the last century, before the days of blogs, Facebook and Twitter. After a stint as an online tech journo in London, she worked in public relations and marketing in the UK and South Africa. She is currently a freelance journalist based in Cape Town, as well as one of the founders of a mobile child safety company, Mobiflock.