Tel: +86-534-2729820
Home > News > Content

Shandong Disineer Disinfection Science and Technology Inc

Add:No.1818 of East Tianqu Road, Dezhou City, Shandong, China

Contact:Kevin Liu




Medical Instruments Product Cleaning Process Validation Guide

Medical equipment products due to the production environment, the production process, raw materials, personnel and other reasons, often inevitably with some pollutants, it is necessary to clean the product. For the use of products before sterilization or disinfection, cleaning is the use of liquid solvents in accordance with certain procedures to remove the pollutants on the product to reduce the initial product before the sterilization to ensure that the final product sterilization or disinfection effect.

The product cleaning process confirms that sufficient data is collected by appropriate means to demonstrate that the finished product is cleaned in accordance with the specified method and that the intended cleaning effect is consistently achieved. In order to avoid contamination of the product after cleaning and reduce the initial contamination of the bacteria before sterilization, it should also consider and confirm the dry product after cleaning, the initial packaging and other links, the inspection guide does not contain the part of the content.


The purpose of this guide is to help the Beijing medical device manufacturers to carry out product cleaning process confirmation to provide a reference.

This inspection guide is suitable for the use of sterilization or disinfection before the product cleaning process to confirm, given the product cleaning process should be considered factors, process validation process and requirements.

(A) the cleaning process and process to confirm the factors should be considered

For a defined product, the cleaning effect depends on the cleaning process. Production enterprises should be based on the production process and pollution products, select the appropriate cleaning process, if necessary, can be cleaned in stages, but should confirm the various stages of the cleaning process. Production enterprises in the choice of product cleaning process and process validation should consider the following aspects:

1. product contamination

Should be combined with the production process analysis of the various stages of the assessment of pollution sources, and to assess the possible pollution and pollution. Should be appropriate for different pollution to take the appropriate way to reduce the pollution to an acceptable level.

2. Selection of cleaning method

The choice of cleaning method should generally consider the product material, structure and cleaning needs to achieve the effect and so on. Medical equipment products common cleaning methods are manual cleaning, automated cleaning, and the combination of two methods. These two cleaning methods are widely used in actual production. Manual cleaning method is mainly hand-held cleaning tools, in accordance with the scheduled requirements of cleaning products. Commonly used cleaning tools are generally able to spray cleaning agents and leaching spray guns, brushes, nylon cleaning blocks and so on. Automatic cleaning method is automated by the specialized equipment in accordance with a certain procedure to automatically complete the entire cleaning process. Commonly have ultrasonic cleaning, high pressure spray cleaning and so on. As a result of manual cleaning, there are certain differences between the individual staff, which led to the existence of a certain degree of uncontrollable cleaning process, so the conditions should be taken as far as possible when the automatic cleaning method. During manual cleaning, the factors that affect the cleaning effect should be evaluated. If the variable factor is specified, the corresponding worst case should be considered during the cleaning verification process.

3. Environmental requirements for the cleaning process

The production environment of the cleaning process should be determined according to the production process and intended use of the product, and the setting of the environmental level shall meet the specific requirements of the regulatory requirements. For sterile and implantable medical devices, the environmental control of the final cleaning process should comply with the requirements of the sterile and implantable medical device appendix. For the product is not the end of the cleaning process (such as rough washing), where the production environment without special requirements, according to product requirements to determine the appropriate production environment.

4. Selection of cleaning agents

Cleaners should be effective in dissolving contaminants, do not corrode cleaning equipment and medical device products, and are themselves easily removed. It is recommended to use a special cleaning agent, generally do not use household cleaning agents. The name of the cleaning agent, the main ingredient, the cleaning concentration and the method of formulating the cleaning agent should be clarified. If necessary, verify or evaluate whether the amount of detergent residue is within the permissible limits. Production enterprises can also be based on the nature of pollutants and product materials to prepare their own cleaning agents.

5. Product cleaning solvent

Medical equipment The most commonly used solvent in the cleaning process is water, including purified water, water for injection and so on. (GMP regulations), due to special structure, chemical properties, the nature of pollutants and other factors, may also use organic solvents, common with ethanol and other volatile good, but also the use of water as a solvent, Lowly toxic solvents.

6. Common cleaning process parameters

(1) the number of cleaning;

(2) cleaning agent varieties and cleaning with the concentration;

(3) cleaning media, such as purified water, water for injection, alcohol, etc .;

(4) cleaning time;

(5) the temperature of the cleaning;

(6) water and / or water level;

(7) the maximum number of cleaning products and placing the way;

(8) ultrasonic frequency (ultrasonic cleaning method);

(9) the number of cleaning liquid use;

(10) water pressure and flow rate (high pressure spray method).

7. Typical model selection

The cleaning process of the product is confirmed by selecting a typical model for a representative product. Representative products and typical models of choice should take into account the different products of the material, structure, processing technology, production environment and other factors. When introducing new products, it is necessary to evaluate whether the product is suitable for the cleaning process; if necessary, it should be re-confirmed.

8. Accept criteria and test methods

Production enterprises according to the specific circumstances of the product to determine their own operation to confirm and confirm the performance of the test items and test samples of the extraction methods and quantity. Under normal circumstances, should not only choose a visual observation of a. Common inspection items are:

(1) Visual observation. There should be no obvious paint, grease, flux, welding slag, heat treatment or thermoforming oxide, dust, garbage, metal or abrasive particles and waste, no significant damage. Visual observation should be carried out at a certain light level, including the usual and supplementary lighting. If necessary, visual observation should be supplemented by pipe mirrors, mirrors and other auxiliary tools to check the surface that is difficult to see. The surface of the lamp should be kept on the surface of the test.

(2) Wipe test. Wipe with a high-purity solvent (but not saturated) with a clean, cotton-free white cotton cloth to evaluate the surface cleanliness that can not be directly visualized.

(3) detection of biological load after product cleaning. Detection methods can be found in the "2015 Edition Pharmacopoeia", "sterilization of medical devices microbiology method Part 1: the total number of microorganisms on the product to detect the initial pollution of cleaning products" (GB / T 19973.1- 2005 / ISO 11737-1: 1995 ).

(4) product particulate contamination detection (when the product has a particle limit). Industry standards require the implementation of industry standards, such as "one-time use of anesthesia filter" (YY0321.3-2009). No standard requirements, refer to the "2015 Edition Pharmacopoeia" in the insoluble microparticle inspection method to detect the cleaning products of particles.

(5) other items, such as cleaning agents, cleaning before and after cleaning water particles or PH changes.

(B) the relevant requirements for the confirmation of the cleaning process

The cleaning process should confirm that the cleaning process can continue to achieve the desired cleaning effect within a range of cleaning parameters.

Working group

The process validation team should be established and the responsibilities of the team members should be clarified. Group members generally come from the production department, quality department, research and development department and so on. The process validation team should develop a process validation plan and complete the validation process in accordance with the program to form a confirmation record and a confirmation report.

2. The confirmation program generally includes the following:

(1) verification purposes;

(2) the applicable product range, the typical product for process confirmation and the reasons for the selection;

(3) the process to confirm the composition of the team members and their respective duties;

(4) the cleaning process and cleaning methods taken;

(5) the cleaning process parameters to be confirmed;

(6) testing items, methods, sampling principles and acceptable criteria;

(7) the equipment to be used, the list of facilities (including weighing, monitoring and recording equipment) and their calibration status;

(8) Records to be retained.

3. Process confirmation link and request

Generally divided into installation confirmation (IQ), running confirmation (OQ), performance confirmation (PQ) three processes.

(1) Installation confirmation (IQ) means that there is objective evidence to support, that is properly taken into account all the manufacturers meet the specifications of the process equipment and auxiliary installation system, the main layout and equipment suppliers. General should include the following:

1) the environment of the cleaning process should meet the requirements;

2) the solvent used in the cleaning process should meet the requirements;

3) the cleaning process will not cause product performance, other processes and clean room environment pollution;

4) the use of equipment cleaning, should have a random file equipment, such as the use of instructions;

5) the use of equipment (such as ultrasonic cleaning machine) cleaning, should confirm the installation conditions, such as working power; equipment can be set according to set the normal operation parameters, such as ultrasonic frequency, cleaning time, temperature,

6) the use of automated cleaning, equipment should be developed operating procedures;

7) manual cleaning, should be confirmed with a cleaning tool;

8) Training and qualification of operators and inspectors. Training should generally include cleaning equipment operating procedures, should also include the relevant clean room management system, product cleaning and other aspects of the content;

9) the preparation of product cleaning process on the production and inspection procedures and related systems.

(2) Operation confirmation (OQ) refers to the scope of control of process parameters by means of objective evidence to confirm that the product meets all expected cleaning effects.

1) The device can be operated according to the parameters of the intended design;

2) Select the typical model of the representative product, through the parameter confirmation to establish the appropriate cleaning process parameters. Usually through the worst combination of cleaning process parameters to clean, the product should be cleaned and should not be damaged, such as the highest, lowest temperature, the shortest cleaning time, the minimum number of cleaning, the minimum detergent concentration;

3) Verify the suitability of the product cleaning procedure for operating procedures.

(3) Performance confirmation (PQ) means that through objective evidence to prove that under the conditions specified, through the cleaning process can be continuously washed to meet all the requirements of the product.

1) should be used in accordance with the normal process of production of products for performance confirmation. Should be through the expected use of the cleaning process;

2) Key materials for batch production for cleaning process performance validation should be provided by approved suppliers, otherwise it is necessary to assess possible risks;

3) the final process to determine the specific cleaning process and process parameters to determine the relevant operating procedures.

4. Confirm again

In order to ensure that the process is in a controlled state, it should generally be re-confirmed in the following circumstances:

(1) after a certain period;

(2) Significant changes in product quality, such as product structure, material, cleaning process change;

(3) there are new products appear, and can not be covered by the original model.

5. In the process of product quality monitoring, continuous process parameter monitoring should be used to support the product cleaning process in a controlled state. When the trend of gradual changes, it should be assessed, if necessary, take appropriate measures to ensure that the cleaning process is in a controlled state.

(C) documents that should be formed

1. Approved verification program, which should at least clarify the process validation team and its staff division, verification program, verification implementation plan, acceptable standards.

2. Records that should be retained during the verification process (including environmental monitoring, cleaning water monitoring records).

3. Confirmation process requires access to or retention of the system, instructions and so on.

4. Approved validation reports, at least the final identified process parameters.

5. According to the confirmation results formed by the cleaning operation procedures.