Bioburden testing is used to check the microbial load in a product, and this test helps monitor the microbial presence in raw materials, finished products or during the manufacturing process. The bioburden test is crucial prior to commercialization of the product, especially in the pharmaceutical, cosmetics or biocide industry. The test will ensure the product is safe to use and conducted according to USP 61 and ISO 11737-1:2006. .
Sterility testing aims at the medical devices labelled as sterile by the manufacturers. Medical device sterilization process (reusable medical equipment) and commercially available sterile medical devices fell under this category. This test checks the microbial presence of the product and ensures its safety of the product. Sterility test follows the procedure based on USP 71 or ISO 11737-2:1998.
Environmental monitoring focuses on the hygiene in your facility or premises. Disinfection and routine cleaning are standard practices in most public facilities. However, the effectiveness of the disinfection process is essential to prevent outbreaks and diseases. Environmental hygiene mainly affects immunocompromised people. RWL conduct surface monitoring (any porous or non-porous surface) and air monitoring. Surface monitoring was conducted using the swab method to check the effectiveness of disinfection procedures and determine the bacterial count level. Air monitoring using active sampling (air sampler) and passive sampling (settle plates).
Consultancy is the core part of ‘Real World Labs’, and we support customers and manufacturers based on their requirements. RWL has extensive knowledge of Regulatory Systems, particularly the Biocidal Products Regulation in the Australian and European standards. RWL team have experience in working with biocidal development. RWL can support the manufacturers in improving the current biocidal products or developing novel products according to customers’ demands. We support your product and marketing initiatives to prevent emerging health risks such as Clostridioides difficile, MRSA (Methicillin-resistant Staphylococcus aureus), Acinetobacter and ESBLs (extended-spectrum beta-lactamase). The real-world lab offers cost-effective microbiology contract research and development services to companies involved in producing medical devices and antimicrobial products. Product development supported by standard regulatory testing to substantiate product label claims. RWL work closely with our clients to provide microbiological support to complement your existing expertise in product development. RWL offer efficient and economical antimicrobial agent screening against bacteria (including antibiotic-resistant and spores) and fungi. RWL designs and implements field trials of products.
If any requirements were not meeting standard protocol, the RWL team could modify or design the test method or conditions according to the manufacturer’s customer’s requirement.