Cleaning processes in the Pharma and Medical field
The cleaning process that is developed and used in the pharmaceutical, medical, cosmetic, and food industries must be both effective and proven, while at the same time not endangering the patient or the operator.
Cleaning processes are considered to have an impact on the patient’s safety and product quality, and as such, it is required by the health and food authorities to undergo a defined validation process to meet strict criteria.
To choose the appropriate cleaning material, it’s critical to minimize the risks, to treat possible contamination and cross-contamination, and to achieve operational efficiency and lowering costs.
When choosing a cleaning material, there are several important parameters to consider:
- Effectiveness – Ensure success by achieving a good level of cleanliness in the final cleaning stage and that the actual cleaning process itself is not overly burdensome.
- Work safety – Make sure that all employees who clean tools and equipment are not exposed to any safety risk and that the cleaning agent does not make contact with the skin, eyes, or gets inhaled. Also, one needs to be aware of chemical reactions with other substances.
- Patient Safety – It is necessary to take into account that there is a theoretical chance that the cleaning material residuals may not be adequately washed off and consequently could appear in the final product. Cleaning products usually have a high level of toxicity, any leftovers that may remain in the product potentially endanger the user.
- Availability – The material should be available through at least one distributor in the appropriate location. The distributor must be reliable and recognized as such at a business level so that there is no situation whereby the cleaning material is not provided on time and at the required quality level.
- Price – Cleaning agents can be pretty costly. If you know how to choose the correct detergent for the type of product or contaminants that you want to remove, then you will save money, not by choosing necessarily the most expensive, but the material that cleans the best.
- Concentration – The concentration of the cleaning agent should be as low as possible for two reasons; 1. the price and 2. the toxicity level. Working with high concentrations of cleaning agents increases the chances that you will not be able to “get rid of it” during the cleaning process, or that you will need to use many rinses with “expensive water,” which also increases cleaning costs and cleaning process times.
- Corrosion – Ensure that the detergent does not cause damage (short-term or long-term) to the surface of the equipment. Materials used in cleaning equipment often consist of stainless steel surfaces, titanium, faucets, seals, etc. All of which can easily corrode or rust.
- Disinfection – Decide whether the substance should be one that disinfects effectively or just cleans.
- Spores – Define whether you need an agent that kills spores (sporocyde).
- Analytical tests – Besides the ability to identify contaminants and residues of active materials, the analytical laboratory should develop methods for identifying the residues on the products and cleaning agents used.
- Interaction with product residues – Make sure that the detergent does not chemically react with product residuals and does not create new compounds or decompose the materials that you need.
- Foam – If the cleaning material you choose creates a lot of foam, you should avoid using it as much as possible. The residue the foam leaves behind can be problematic
- Shelf Life – Make sure that the chosen cleaning agent has a long shelf-life. This helps to keep down cost and shows stability in the product.
- Temperature – The main rule of thumb is that the higher the temperature of the cleaning process, the greater the efficiency of the cleaning process. Make sure the detergent is also effective at room temperature and does not require heating or additional utilities, cost or time. Also, make sure the boiling temperature of the detergent is not too low because if you add a heating process to the cleaning stage, there’s a risk that the product will evaporate and could potentially cause a safety issue for the operator. or those in the vicinity.
- Environment – Make sure that all cleaning materials can be disposed of via the regular drainage system and that it does not require anything special to be disposed of. In the worst case scenario, you should be willing to compromise on material that has been diluted before dumping into the drain.
- Mechanical cleaning operations – For safety and efficiency reasons, you should choose a detergent that works well when soaking and does not require scrubbing.
Choosing the most effective and uniform method of cleaning can be confusing, and it is not an easy task.
If your business needs expertise on the proper cleaning methods for your company specifically, or if you need professional writing and execution of cleaning validation, we have accumulated years of experience in this area and would be more than happy to meet your needs.
Please contact our team at Bio-Chem Ltd. for further details or any other information