ISO 13485:2016 accreditation is a quality management system which ensures that organisations meet the needs of all customers and stakeholders, while adhering to all product statutory and regulatory requirements according to the ISO (International Organisation of Standardisation). ISO 13485:2016 refers to quality management and management principles. KIT SA has been audited by a third party and conforms to the standards outlined in ISO and is proud to be officially ISO 13485:2016 certified.

A cleanroom is a controlled environment with a low level of pollutants, such as airborne microbes, dust, aerosol particles and chemical vapours. They are used in almost every industry where small particles can have a negative impact on the manufacturing process, as well as in scientific research. Our ISO Class 8 Cleanroom maintains a count of less than 3 520 000 particles/m3 for particles less than 0.5µm in size; and less than 29 300 particles/m3 for particles less than 5µm in size. Temperature is controlled at 22ºC (±2ºC) and the air is cycled a minimum of 4 times per hour. This provides us with a strictly-regulated environment in which to manufacture safe and sterile products our customers can trust.

Microbial testing is a process used to determine the presence and levels of various microorganisms in a product. To ensure accurate and reliable results, we outsource our testing to independent laboratories equipped to perform the various tests.

All our foam products are made with flexible polyurethane foam (FPF), which is created by combining various chemicals to form a reaction. FPFs are increasingly common in our daily lives, and are completely safe. Our customisable foam inserts can be produced in a variety of colours and shapes to meet specific requirements and are ideal for preventing breakage in pharmaceutical primary packaging.

Silica gel is a porous, non-toxic material with exceptional moisture-absorbing capabilities. Available in various bead or crystal sizes, it effectively preserves product quality by preventing moisture damage. Different types of silica gel are designed to target specific moisture levels and gasses, ensuring optimal protection for a wide range of products.

Primary packaging is the packaging that is in direct contact with your product, the first layer in which your product is contained. For industries such as pharmaceuticals, food and beverages, this packaging is of paramount importance, as it the last line of defence against contamination – if the primary packaging is compromised, so is the product. Primary packaging must therefore be ideally suited to both the product itself and any subsequent packaging layers to ensure optimal protection and integrity.

We are regularly audited by our pharmaceutical customers, as well as other clients who source their primary packaging from us. To further guarantee reliable quality, we have annual SABS ISO audits to ensure that we are completely compliant and up to date with the latest ISO 13485:2016 standards, and that all procedures are adhered to correctly. We also perform our own audits on all our suppliers to ensure they adhere to our high quality standards.

Yes, KIT has a robust Corrective Action Report (CAR) process in place. Both internal teams and customers can initiate CARs. These reports enable thorough investigations into product issues, identifying root causes and implementing corrective actions. By proactively addressing problems, we are able to quickly prevent recurring issues, so we can maintain the high quality standards our customers know and trust.

Auditing is a rigorous process that meticulously examines the entire production chain, from raw materials to finished product. This comprehensive evaluation includes inspections of all relevant departments, ensuring adherence to quality standards and procedures. External auditors conduct random product audits, tracing the manufacturing process from start to finish. Our audits also encompass physical facility and documentation examinations, verifying compliance with SABS ISO 13485:2016 standards.

Maxihealth is our registered trademark, representing the highest quality standards across our product range. The Maxihealth logo is a symbol of our commitment to excellence, assuring customers of the superior quality and performance of our products.

Maxihealth provides clear and consistent product identification, highlighting products that are linked to the relevant Certificate of Compliance (COC) and product specifications. This ensures product traceability and reinforces our commitment to quality for both manufacturers and end-users.

Molecular sieves are crystalline materials with precisely sized pores capable of selectively absorbing molecules. Often derived from zeolites, they are highly effective for separating, dehydrating and purifying various gas and liquid streams, including hydrocarbons and non-hydrocarbons. Their ability to remove contaminants like COS makes them indispensable in many industrial processes.

By effectively absorbing moisture and regulating humidity levels within packaging, silica gel desiccants and other absorbent packs inhibit the growth of mould, bacteria and other microorganisms that cause spoilage. They also slow down the oxidation process, which helps retain essential vitamins, minerals and flavours. This ultimately reduces food waste and ensures that consumers receive fresh products with optimal nutritional value.

Absolutely! KIT specialises in creating customised solutions to meet your exact needs. Our experienced team collaborates closely with clients to develop products tailored to specific requirements. From product dimensions and packaging materials to custom printing and artwork, we offer a high degree of flexibility to ensure your complete satisfaction. Our efficient production lines can accommodate various product sizes and specifications, allowing us to deliver solutions that seamlessly integrate into your operations.

The simple answer is that there is no size limit. The optimal size depends on several factors, including the type of cargo, packaging method, transportation duration and handling conditions. Our experts will carefully assess these variables to recommend the most suitable silica gel pack size and type to effectively protect your goods during transit.

Yes. A batch number is allocated to raw materials so they can be traced throughout the manufacturing process and linked to every product KIT supplies, giving you complete peace of mind.