Standard Operating Procedure for Cleaning the 60 cu. ft. Pharmaceutical V- Blender

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Table of Contents

Purpose
Scope
Definitions of words used in the paper
List of equipment used in cleaning the V-blender
Cleaning solutions
Responsible persons
Procedure
References to Standards, Manuals or relates Standard Operating Procedure
Works Cited

Purpose

V-blenders are used mostly in pharmaceutical companies. The blender is the key played in the mixing process of various components used in the production of drugs. The paper aims to present a standard procedure to be used in cleaning the V-blender. This will ensure that the components produced meet quality standards. There will be defective products from contamination from other components from the V-blender (Tekchandaney 2).

Scope

This information applies to all individuals who may use the V-blender at some point in the production process. This aids in the cleaning of the blender. Care should also be taken to ensure the surrounding and components to be mixed are not contaminated.

Definitions of words used in the paper

IPA means Isopropyl alcohol
Approved detergents – are detergents that have been recommended for cleaning by the facility and specified for the V- blender
Harmful chemicals – this are substances that when exposed or released to the environment may alter the natural state the environment that might result to destruction of the flora and fauna and harm the human population

List of equipment used in cleaning the V-blender

Gallons of well-labeled plastic buckets
Disposable wipes
Purified wipes for cleaning to ensure sterility of the gasket
Brush and long handle mobs
Specific vacuum cleaner for the gasket
Water hoses clearly labeled for the purified water, cold and hot purified water
Specialized flash light for observation after cleaning

Cleaning solutions

Approved detergents for the purpose at hand
70% IPA used to sanitize the V-blender
Distilled water

Responsible persons

There should be at least two technicians assigned to clean the V-blender. They should be well trained and approved by the relevant bodies in the pharmaceutical industry. This ensures there is professionalism and minimizes the likelihood of defective drugs.

Procedure

Tag the equipment with a cleaning label, indicating not in used.
The technicians ensure they have the required protective clothing before the start of the process
Disconnect the power cable and remove the lid
Remove any visible materials from the blender (gasket) and place them in disposable sterile bags. This ensures that they are not disposed dangerously. They can be harmful chemicals to the people and the environment.
Cleaning the gasket starts by using a long handle mob
Spray the gasket with hot purified water and close the lid. Switch on the power and run the blender on a low knob to mix the detergents and cleaning agents.
Discard the contents using the discharge valve.
Use the brush to remove any residual remaining in the gasket
Fill the gasket with cold water and run the blender again on a low knob
Discard the contents using the lower valve.
Use the flashlight to check if there is any residual remaining in the gasket. If there is any residual, the procedure is repeated from step 5.
After ensuring that there is no residual, fill the gasket with 10 USG of IPA using the plastic gallons. Close the gasket and run the blender on a low knob again to ensure the solution covers the entire surface.
Drain the solution
Wipe the exterior part that may have been exposed to the cleaning agents or solutions using disposable wipes.
Then use the purity wipes to wipe the inside of the gasket. This is to remove the IPA solution.
Allow a 30 minutes window before closing the lid of the blender.
Collect the disposable wipes and sterile bags drop them in the allocated garbage bins.
Clean the brush, gallons, and mobs, and then wipe the floor dry from any liquid or detergent.
Ensure that the cleaning equipment and remaining solutions and detergents are returned to their correct storage area. This will avoid any mixing and ease of access by other users.
Inspect the V-blender from any defaults. This may be from rust leaking breakages of spillage. A standard form is t filled, signed, and handed to the housekeeping manager. This is critical for referencing, inspection, and audit in case any issue arises.
Remove the protective clothing and hand over to housekeeping for cleaning.

References to Standards, Manuals or relates Standard Operating Procedure

The World Health Organization (WHO) provides some cleaning validation for equipments. This is to ensure that there is no contamination of products. WHO also stresses the need of using soluble detergents so as they do not leave residual on the cleaned surfaces. There is also need for a standard cleaning procedure for equipments. The process is documented to show evidence that there was cleaning on a certain date. An organization can choose to have routine cleaning exercises on major cleaning conducted at specified dates. WHO also emphasizes the need to have trained personnel to conduct the cleaning processes. This will ensure the right cleaning agents and equipment are used in the process. Overall, an organization is able to assure quality in its production process (Evans and William 47).

Quality assurance is one of the components of quality management. This ensures that there are systems that proactively define processes. This leaves no room for errors and defective products. One of the factors that aid in reducing defects includes understanding the process. If technicians understand, the standard operating procedure for cleaning equipments there will be lesser errors moving towards zero defects. Most defects are caused by human errors that may include forgetfulness, misunderstanding, wrong identification, snowlines, and ignorance. Organizations do their level best to avoid defects, as they are costly. The costs of defects include scrap, rework, warranty costs, inspection costs, and legal suits filed by aggrieved parties. These costs imply that the organizations revenues are utilized more.

This affects the bottom line of an organization. There are quality standards guidelines given by the international Standards Organization (ISO). They guide and organization towards zero defects in its processes. After cleaning recommendations can be made on the process and scored on a score sheet. If the process is above average then the equipment is safe. If it fails to meet the average score then a review on the cleaning process can be conducted to ascertain the quality. It is vital to note that a mistake in the mixing of a product may be discovered much later when many batches of a product have been packed already. To avoid waste measures should be taken to follow provided guidelines in processes. Failure to do so results in duplication of defects throughout a process. There are companies that with draw a whole range of products produced in certain periods due to defects. This is normally costly in terms of revenue and image of an organization. Millions are paid in compensation, refunds, and replacement of products. It is prudent to get it right at the very beginning to avoid the consequences (Evans and William 32).

Works Cited

Evans, James, and William Lindsay. The management and control of quality, 5^th ed. The University of Michigan: West Pub. Co. 2002. Print

Tekchandaney, Jayesh. V-Blenders. 2009. Web.

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