Device type

Mixing tanks, tablet presses, capsule fillers, centrifuges, granulators, filling lines, mixers, conveyors, filters, fluid lines, batch process tanks, tubes and flasks all need to be cleaned thoroughly. Design of equipment should be taken into consideration. By the nature of its construction, some types of equipment will be more difficult to clean than others. Hidden parts and blind holes present unique challenges.

Another important factor to consider is how the tool is used. Are you cleaning a dedicated production system or equipment that is used to produce a range of products? Processing equipment used to produce many products has a greater potential for cross contamination of the material.

It is also important to choose a cleaner that suits the surface of the equipment you are cleaning. The cleaner manufacturer should be able to guide you and provide compatibility studies for their products.

Cleaning method and location

Clean-in-place (CIP) or clean-out-of-place (COP)?

CIP is commonly used for large systems and components that cannot be easily separated. CIP often results in less downtime as it eliminates the need to isolate or move devices. Automated systems, spray systems, and immersions are all examples of CIP operations.

COP is often used for small pieces of equipment or small parts of larger equipment that can be removed and reassembled after cleaning. COP may include either hand washing or the use of machine washers. Specific instructions should be followed for disassembling and re-assembling devices.

Which cleaning method would you use?

Manual, ultrasonic, spray, machine and automatic systems are used for cleaning of pharmaceutical equipment. The cleaning method used will affect your choice of detergent. Automatic parts cleaners and high-pressure washers require less foaming detergent.

Temperature

In most cases, raising the temperature is one of the best ways to speed up or improve the cleaning process. The temperature parameter used for any personal cleaning application will depend on the equipment and soil present, as well as your choice of detergent and wash method. Check with the manufacturer for the maximum suggested operating temperature for your detergent.

dwell time

The length of the cleaning cycle contributes to the effectiveness of your cleaning application. In most cases, a longer stay time will improve results. However, all factors - soil, temperature, substrate, detergent and cleaning method - should be taken into consideration.

Rinse step

Rinsing as a whole should follow cleanliness. Rinsing occurs by removing any excess detergent left on the item. For critical cleaning applications, it is best to use deionized or distilled water, as rinsing with ordinary water can introduce new contaminants.

Recognition of cleanliness

Cleanliness verification is a part of the regulatory compliance process for cleaning pharmaceutical processing equipment. Verification ensures that all equipment is washed according to the previously set standards and all traces of soil and detergent are removed. Validation methods are unique to each detergent and should be available from most cleaner manufacturers.

Download the IPC's "7 Step Guide to the Proper Use of Critical Cleaner" for more information on setting up the cleaning system.

Need help choosing the right specialty cleaner for your pharmaceutical cleaning application? Contact one of the International Product Corporation (IPC) technical experts or request a sample of free cleaners for testing. All IPC-specific cleaners are registered with the NSF as A1 cleaners and can be validated in FDA procedures.

soil

The actual manufacturing process, such as kerosene or oil, dust or minerals found on pharmaceutical processing equipment, may lead to traces of various materials used in production or soil. Understanding the soil that exists will guide your choice of detergent.

Gels, polyethylene glycol, oils, titanium dioxide, dyes, silicones, flavorings, petrolatum, paraffin, proteins, steroids, sugars, alcohols, stearates, and cornstarch are some of the specific foulants often found on pharmaceutical processing equipment.

Each type of soil is unique and requires proper detergent to thoroughly clean the surface. Choose a cleaner that will best attack the soil you are trying to remove. Alkaline cleaners are the best choice for soil cleaning such as gels, dyes, and petrolatum, while citric acid-based cleaners are better suited to remove titanium dioxide. Protein or starch-based soils may require the use of enzyme cleaners. Use the table below to help match the most effective type of cleaner in each type of soil.

Device type