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Ultimate Cleaning Guide For Pharmaceutical Equipment

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Brittany Wolfe
Ultimate Cleaning Guide For Pharmaceutical Equipment

If you’re in the pharmaceutical manufacturing business, you would know the importance of keeping the pharmaceutical processing equipment clean. Clean equipment not only increases the efficiency of the production process but also increases the longevity of the machinery.

 

When it comes to the cleaning of pharmaceutical equipment, whether it is a new granulator or a used capsule filling machine, the task can be quite challenging. Choosing the right cleaning method along with the right product or ingredient is highly essential for proper cleaning of the equipment. This guide will give a detailed insight into the cleaning of pharmaceutical processing equipment.

 

Why is it important to clean pharmaceutical instruments?

Cleaning pharmaceutical equipment is highly essential for maintaining the quality of production as well as increasing the life of the equipment. There are multiple reasons for cleaning a pharmaceutical instrument and the following are some of them.

 

- It helps remove all trace components from the surface of the equipment and reduces the risk of contaminating the next product production. Along with cleaning the equipment mechanical polishing, too, can be done to improve the surface cleanability of the equipment. The mechanical polishing process reduces adhesion and thus leads to a significant reduction in product buildup.

 

- It helps maintain the quality of the product.

 

- Cleaning the surface of the equipment makes it ready for disinfection. A piece of machinery cannot be disinfected if its surface is not properly clean. 

 

-  When pharmaceutical equipment is cleaned regularly it increases productivity by enhancing the performance of the machine.

 

- Regular cleaning prevents any malfunction of the equipment relating to product contamination.

 

- A clean work environment not only enhances the process of manufacture but also ensures the safety of the workers as well.

 

Factors to be taken into consideration while cleaning a pharmaceutical equipment

 

When it comes to the cleaning of the pharmaceutical equipment a number of different factors need to be taken into consideration. The following factors should be in compliance with all federal regulations.

- Cleaning methods

When it comes to cleaning pharmaceutical equipment there are two procedures, cleaning-in-place (CIP) and cleaning- out-of-place (COP). CIP procedures are mostly used for large scale and heavy equipment that cannot be taken apart easily. In this cleaning method, spray systems and immersion procedures are followed to clean the equipment.

COP system, on the other hand, is generally used for smaller sized equipment or on equipment with removable parts. The parts of the machinery are either cleaned manually or using machine washers and they offer a much thorough cleaning of the machine although the downtime is much higher in case of this type of cleaning.

 

- Cleaning the soils

Soils present in the pharmaceutical equipment are the leftover ingredients deposited on the surface of a equipment from various pharmaceutical production. The deposition may be in the form of oil, grease, minerals, and dust, etc. The nature of the soil needs to be properly understood to select the right cleaning agent for the machinery.

The surface of equipment can be contaminated with soils of different types like paraffin, glycol, gels, silicon, titanium, proteins, stearates, flavorings, sugars, dyes, edible oils, steroids and much more. The federal regulations have established a specific type of cleaning agent for each type of deposition and knowing the type of soil you can choose the right one for cleaning.

 

- Type of equipment

Whether you’re using a used granulator or a new one, certain equipment like granulators, capsule filling machines, flasks, tubes, and batch process tanks need a very thorough cleaning to avoid contamination. Also, some equipment are easier to clean than others. Special care is needed to be taken for equipment that is involved in the production of a wide range of products so as to avoid the chances of cross-contamination.

 

Ways to enhance the cleaning process

The cleaning of pharmaceutical equipment involves automated, manual, and spray systems and there are certain techniques that you can follow to enhance the cleaning procedure and derive a more improved result.

 

- Increase the dwell time

The longer the cleaning cycle, the more effective it is in cleaning your equipment, and as such, the longer the dwell time is, the more improvement you will see in your results. But when increasing the dwell time keep in mind other factors like temperature, choice of detergent and type of soils, etc.

 

- Increase the temperature

One of the most effective ways to improve and speed up the cleaning procedure is to increase the temperature. The extent to which you can increase the temperature for equipment depends on the type of soils present as well as the choice of detergent. 

 

- Rinsing after cleaning

Once the cleaning process of the equipment is completed, it should be followed by a thorough rinsing to remove any leftover detergent in the equipment surface. Deionized or distilled water should be used to rinse the equipment as normal water can add new impurities in the equipment.

 

How to establish a cleaning procedure?

When it comes to cleaning pharmaceutical processing equipment, you need to set up complete documentation of the cleaning procedure for all the equipment. The federal regulations dictate a detailed and specific description of the cleaning procedure for each of the equipment and this document should include the following parameter:

 

- A frequency chart for cleaning the equipment, describing how often you’ll need to clean the equipment and the time required between processing and cleaning the products.

 

- The tools to be used in the process.

 

- Detailed and sequenced steps of the entire cleaning process.

 

- The method of cleaning chosen, whether CIP or COP.

 

- Detailed instruction on the disassembly and re-assembling of the equipment.

 

- Type of cleaning agent to be used.

 

- Type of water used.

 

- Guidelines for drying and storage.

 

- Cleaning validation processes.

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