¿Cómo controlar la primera fuente de contaminación en la sala blanca?

La contaminación de las salas blancas es un problema común al que se enfrentan muchos fabricantes asépticos por muchas razones. Desafortunadamente, la causa principal más común son los operadores que trabajan en estas salas blancas. ¿Por qué?

En primer lugar, las personas son la primera fuente importante de contaminación del proceso de producción farmacéutica.

• Los principales riesgos de la producción farmacéutica son la contaminación, la confusión y los errores.
• Los factores de riesgo de la producción farmacéutica incluyen endógenos y exógenos.
• Los factores endógenos incluyen planta, equipo, sistemas, calidad de la materia prima y subsidiaria, proceso.
• Los factores exógenos incluyen riesgos causados ​​por el personal.
• Hay quien dice que por riesgo aséptico, los microorganismos son la primera fuente de contaminación. Esto está mal, los microorganismos son la primera contaminación, pero no la primera fuente de contaminación. Entre los diversos riesgos, los factores de riesgo humanos son particularmente importantes, incluido el nivel de carga biológica del personal, el tiempo que el personal permanece en el área limpia, la frecuencia del impacto de la carga biológica del personal y el coeficiente de transferencia. El coeficiente de transferencia representa la carga biológica en el producto y también indica la probabilidad de que entren microorganismos en el producto.
• La planta, equipos, sistemas, calidad de materias primas y auxiliares, procesos, etc. han sido auditados, validados, verificados por los proveedores, y …… debe estar bien controlado. El siguiente paso es la gestión, control y mantenimiento de la planta, equipos, sistemas, calidad de materias primas y auxiliares y procesos por parte del personal. El principio fundamental de la implementación de GMP es reducir la contaminación, la confusión y los errores, y en el proceso de producción, la gran mayoría de la contaminación, la confusión y los errores de causa raíz se deben al factor humano.
• Por tanto: las personas son la primera gran fuente de contaminación en la producción de drogas.
  

En segundo lugar, los factores de riesgo aportados por el personal.

• Poca conciencia de calidad y calidad general del propio personal.
• Malos hábitos sanitarios del propio personal.
• El estado de salud del personal no es bueno.
• The personnel’s speech and behavior is not standardized
• Low production operation skills of personnel
• Dressing procedures do not guarantee the pollution of the environment by the personnel
• Not strictly in accordance with the dressing procedures for dressing
• Operators do not wash their hands and disinfect their hands as required
• Hardware protection measures can not prevent the pollution brought by the personnel themselves
• Too many people in the clean area
• Clean area personnel action too much, too tedious
• The magnitude of the operator’s movement is too large to bring particle contamination
• Particle contamination caused by the rapid movement of personnel
• Particle contamination caused by personnel talking loudly, sneezing, etc.
• Through the aseptic production area purification dead-end and contaminated
• Staying in a class a clean area for too long
• Improper operation leads to environmental, equipment, drug contamination
• Human surface metabolism brings particles and microbial contamination
• Contamination, confusion or error caused by not operating according to sop, mishandling and the risk of clothing itself

Third, the risk factors brought by cleanroom attire.

1. Workwear style is not correct, easy to hide dirt and grime
2. Material performance (weave characteristics, fiber type, sterility, anti-static, etc.) is not appropriate
3. The material is too thin, the isolation effect is not good, can not block the pollutants
4. Material is not good, more shedding itself
5. The material is too dense, breathability is not good
6. Model selection does not match, too tight personnel discomfort, too loose pollution is easy to spread
7. incorrect operation in the process of dressing human contamination sterile clothing
8. Ambient air pollution sterile clothing
9. Dressing process careless ground contamination sterile clothing
10. Clothes will be shed after multiple sterilizations
11. Workwear rupture cannot block human contamination
12. Work clothes sterilized by secondary contamination
13. The personnel in and out of the worn, not worn work clothes confusion caused by cross-contamination
14. The gloves are too loose or too tight, which brings contamination during operation
15. No regular hand disinfection
16. The mask is too loose, the mouth contaminants into the environment
17. The mask is too tight and too dense, the operator does not breathe well. The risk brought by the personnel, the risk brought by the work clothes is clear, the preventive measures are self-explanatory, the key or the training and management of people must be in place.

Fourth, the management of personnel and team management.

• GMP regulations, guidelines for the implementation of all rely on people to implement, people are the most critical.
• No matter which country’s GMP audit, the first concern is the personnel qualifications and quality management system.
• There must be a good management system.
• There must be a group of highly qualified personnel.
• There must be a proper workflow and operational sop.
• The scope of each person’s responsibilities must be clear.
• Each person must have a good code of conduct and a wealth of expertise.
• Good personal habits, efficient execution.
• Quality control of the whole process.
• Quality management, the key also lies in the management.
• Management, good management of people, good management of things.
• Training: mainly the change of concept
• Training: mainly the formation of habits
• Cooperation: between departments, between each person within the department, relying on communication to solve problems.
• Participation: between the upper and lower levels is not just command and execution, but more participation and advice.
• Support: Support each other.
• Review and feedback.
• Every day, what is each person doing?
• Everyone needs to be clear on how and why they are doing it
• Commissioning, trial run, trial production, culture filling, these processes are the process of training and practice.
• Good rules and regulations, operation sop, strict enforcement.
• GMP should be a self, consciously good habits.

How to control people Contamination in cleanrooms

• People as the source of environmental pollution include their own: hair, skin and other micro-debris, body surface and breathing metabolic products. Personnel carry: various particles and microorganisms attached to the human body, clothing, etc., as well as clothing wear off. These two types of contamination are constantly being generated and spread. Cleanroom operators are the largest source of contamination.
• In a class B clean room, an operator sitting still can release 100,000 to 1 million particles per minute, and a single movement of the hand or head can produce 0.3 um of particles. It will produce 0.3 um of dust about 500,000 particles, the feet move is 1.5 million particles, walking will cause 5 million particles, and fast walking generates 10 million particles. All of these particles come from necrotic hair and shed skin. Other sources of particles are hair spray, cosmetics, hair coloring and exposed non-clean clothing. As you can imagine, this is a huge and deadly contamination for a very demanding sterile area.
• Therefore, it is not enough to control the temperature and humidity in the clean area, but the key is to control the cleanliness. The key to control the cleanliness is to prevent contamination and human contamination, in addition to air filtration.
• The particles in the clean area will increase with the activities of operators, and the air conditioning system and machine operation will also produce particles by continuous vibration. Ordinary clothes, even when wrapped in clean clothes, can add millions of particles to a clean room. In a clean room with a very high level of cleanliness, the operators should only wear clothes that are made of non-shedding material and are tightly woven. Also, sterile underwear is required in sterile areas.
• The human breath contains a large amount of particulate pollution, and each exhalation expels a large amount of water vapor and particulates into the air.
• A smoker’s breath can continuously exhale millions of particles long after smoking.
• Healthy people are a source of many pollutants, and sick people are even worse, especially those with skin rashes and respiratory infections.
• Patients with respiratory tract infections are additional sources of contamination. The only viable way to prevent contamination of people is to completely encase them in layers.
• The material used for clean suits varies depending on the cleanliness requirements, and should be resistant to shedding and contain conductive fibers to discharge static electricity.
• The material’s ability to filter particles and the operator’s comfort in wearing it should also be examined. Every part of the body should be covered. The head should be covered with an inner cap to cover the hair.
• The eyes are also a major source of liquid particles, and in areas where contamination control is important, the operator wears a full shield that completely covers the head and face.
• The head and face can be completely covered. Fully covered body garments that cover the legs, arms, and neck, and better designed work clothes that cover the zipper as well.
• No outside pockets are allowed. The feet are also covered with shoe covers, and some have leg guards attached to the calves. Hands should be covered with at least one pair of gloves.
• Even two pairs of gloves are required for sterile areas. Skin shedding is further controlled with a special emollient that moisturizes the skin, but it must not contain salt or chloride.
• However, it should not contain salts or chlorides. The order of dressing should be from the head down, so that the dust raised in the previous step can be covered by the next part of the
• This allows the dust raised in the previous step to be covered by the next part of the garment, and the gloves to be put on last. In the case of one-piece overalls, sometimes they can only be worn from the bottom up, with the feet and legs first and the arms and head last.

• Extra care should be taken at this point. Clean clothing and wearing procedures to control contamination from personnel are well known, but the most effective prevention
• means is the training, training and retraining of operators, and the implementation, implementation and implementation. In the cleanroom, the people are an important factor in determining the generation of particulate contamination. All personnel working in a cleanroom should be fully aware of the impact of personal hygiene habits on cleanliness.
• Only by knowing clearly what they are doing can they avoid the pollution they bring to the clean environment and even to the drugs.
• Jewelry is not allowed in clean areas, especially rings with sharp corners or edges, as they may pierce gloves or clothing. Do not wear earrings, necklaces, brooches and other protruding or dangling jewelry. Personal items, such as cigarettes, wallets, tissues, paper products, cell phones …… should be stored in a desk or locker and not brought into the cleanroom. In the cleanroom, all clothing pockets must be empty.