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Cleanroom tablet production process control

Clean room tablet production packaging, first check the product name, manufacturer, batch number and quantity of the materials used, wipe the surface of the outer packaging of the materials with a cleaning cloth, and then remove the outer packaging, the materials that cannot be removed from the outer packaging Wipe the outer packaging of the material with 75% ethanol, and pass it into the equipment through the airlock...
Text label: clean room design and installation, clean room engineering, clean room tablet workshop

Clean Tablet Production Process Control


Clean room tablet production packaging, first check the product name, manufacturer, batch number and quantity of the materials used, wipe the surface of the outer packaging of the materials with a cleaning cloth, and then remove the outer packaging, the materials that cannot be removed from the outer packaging Wipe the outer packaging of the material with 75% ethanol, and pass it into the preparation room through the air lock; the crystalline raw and auxiliary materials need to be crushed and sieved, especially the materials that are insoluble in water. The fineness of special raw materials should be smaller; the crushing area is a Class D clean area, and a large amount of dust will be generated during the crushing process. Use a universal pulverizer with a dust removal system, which can capture the dust leaking from the powder collection bag during the pulverization process by a dust catcher.


The batching and feeding of preparations are the key production processes. It is necessary to ensure the accuracy of the prepared materials. Not only should the weighing of the materials be supervised, but also which container the materials are taken from and which new container they are transferred to should be determined by the first Two people review to confirm whether the weight is correct, whether the original container has a proper label, whether the new container is affixed with a proper label, etc. In order to reduce errors and check, the containers used should be marked with a barrel number. Wet granulation is the most widely used granulation method in tablet preparation, mainly using extrusion sieving granulation, high-speed stirring granulation and fluidized bed granulation. The mixing time of each variety of raw materials and auxiliary materials, as well as the granulation, stirring and chopping time should be determined through process verification. Taking high-speed stirring and granulation as an example, in the verification of granulation process parameters, the uniformity of mixing is detected by each mixing time period. The mixing time is determined, and the stirring and chopping time is determined by the mass of particles formed in each stirring and chopping time period. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean workshops.













Clean room In addition to fluidized bed granulation, the preparation and drying of granules can be completed in the same container in sequence, the wet granules prepared by the sieving method and the high-speed stirring method need to be dried by suitable methods such as blast drying Drying in a box or a circulating drying bed; when the wet granules are dried in the fluidized bed, the inlet air temperature, granulation temperature and drying time of the drying equipment should be set; the moisture content of the dry granules should be controlled within the specified range; Use the sieving method to remove large particles of dry granules, or use a rotary or swinging granulator for granulation to ensure uniform particles; send the granulated granules to the mixing room, fill in the operation records, and calculate the yield; clear the site and clean it equipment. Before the granules are mixed, the auxiliary materials that need to be added are weighed according to the process instructions, and poured into the mixer together with the granules and mixed according to the specified time. Sieve preliminary mixing.
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Introduction:

Shipping containers have gained popularity in recent years as affordable and versatile spaces for various purposes. One such purpose is the creation of a pharma clean room, a controlled environment essential for industries like pharmaceuticals, electronics, and biotechnology. Cleanrooms provide a space free of dust, contaminants, and other pollutants, ensuring optimal conditions for sensitive manufacturing processes. While constructing a cleanroom can be a costly endeavor, it is possible to build one on a budget using a shipping container as the base structure. In this article, we will explore how to transform a shipping container into a functional cleanroom without breaking the bank.

The Benefits of a Shipping Container :

Before diving into the details of building a shipping container cleanroom, it's important to understand the benefits it offers. Here are some advantages of opting for a shipping container cleanroom:

1. Cost-Effective Solution: Building a traditional pharma clean room from scratch can be a significant financial investment. On the other hand, utilizing a shipping container as the core structure can considerably reduce costs, allowing businesses to allocate their budgets more efficiently.

2. Flexibility: Shipping containers come in standardized sizes, making them easy to transport and modify according to specific requirements. They can be easily relocated or re-purposed, providing businesses with flexibility as their needs change.

3. Time Savings: Constructing a cleanroom from the ground up can be a time-consuming process. Utilizing a shipping container as the starting point significantly reduces construction time, allowing businesses to have their cleanrooms up and running faster.

4. Sustainability: Repurposing shipping containers helps reduce waste and contributes to a more sustainable approach to construction. By giving containers a second life, businesses can minimize their environmental impact.

Now that we understand the benefits, let's explore the steps involved in building a shipping container cleanroom on a budget.

Gathering the Necessary Materials and :

To begin the construction process, it is essential to gather all the necessary materials and pharma machinery required to transform a shipping container into a cleanroom. Here are the key components you will need:

1. Shipping Container: Start by sourcing a suitable shipping container that meets your size requirements. Look for containers in good condition, ensuring the structure is solid and free from any major damages. Consider the dimensions of the container to accommodate the cleanroom necessities.

2. Insulation Materials: Since shipping containers are not designed to be temperature-controlled, proper insulation is crucial. Use insulation materials such as rigid foam board or spray foam to ensure an airtight and well-insulated environment.

3. Wall and Ceiling Panels: Install pharma clean room-grade wall and ceiling panels for a hygienic and easy-to-clean surface. These panels should have a smooth, non-porous finish and meet the necessary cleanroom standards.

4. HVAC System: Heating, Ventilation, and Air Conditioning (HVAC) systems are vital for maintaining the desired air quality within a cleanroom. Consider the size and specific requirements of your cleanroom to select an HVAC system that effectively controls temperature, humidity, and air filtration.

5. Lighting: Proper lighting is crucial for visibility and maintaining a sterile environment. Install cleanroom-approved LED lights that provide optimal illumination without generating excessive heat.

Preparing the Shipping Container:

Once you have gathered all the necessary materials and pharma machinery, it's time to prepare the shipping container for the cleanroom conversion. Here's what you need to do:

1. Clean and Sterilize: Thoroughly clean and sterilize the shipping container to remove any dirt, debris, and potential contaminants. Disinfect the interior surfaces using suitable cleaning agents to ensure a bacteria-free environment.

2. Seal any Gaps: Inspect the container for any gaps or openings that might compromise the airtightness. Use a high-quality sealant to seal these gaps, paying special attention to areas around doors, windows, and ventilation systems.

3. Insulation Installation: Begin the insulation process by applying the chosen insulation materials to the interior walls, ceiling, and floor of the container. Make sure to follow the manufacturer's instructions to achieve proper insulation.

4. Panel Installation: Install cleanroom-grade wall and ceiling panels over the insulated surfaces. Ensure that they are securely attached and provide a smooth, seamless finish.

5. Installation of HVAC System: Engage a professional HVAC contractor to install the HVAC system suitable for your cleanroom requirements. The contractor will ensure proper installation and calibration of the system, including necessary ductwork and air filtration systems.

Creating a Controlled Environment:

With the container prepared, it's time to focus on creating a controlled environment within the cleanroom. Consider the following factors:

1. Temperature and Humidity Control: Depending on your industry's specific requirements, install equipment that allows precise temperature and humidity control within the cleanroom. This may include heaters, coolers, and humidifiers.

2. Air Filtration: environments require high-quality air filtration to prevent contaminants from entering the space. Install HEPA (High-Efficiency Particulate Air) filters to ensure the air circulating within the cleanroom is free from particles and microparticles.

3. Pressure Differential: Depending on the cleanroom class you aim to achieve, create the necessary pressure differentials to prevent the infiltration of outside air. This is usually achieved by installing laminar airflow systems or using airlocks.

4. Monitoring and Control Systems: Implement a monitoring and control system to supervise and maintain the cleanroom environment. This may include sensors for temperature, humidity, and pressure, as well as an automated control system to regulate these parameters.

5. Electrostatic Discharge (ESD) Protection: If your cleanroom deals with sensitive electronics, consider incorporating ESD protection measures to prevent damage from static electricity. This may include ESD flooring, grounding systems, and proper personnel grounding protocols.

Summary:

Building a shipping container cleanroom on a budget is an excellent solution for businesses looking to establish a controlled manufacturing environment without incurring excessive costs. By repurposing shipping containers and following the outlined steps, you can create a functional cleanroom that meets industry standards while optimizing your resources effectively. Remember to prioritize insulation, air quality control, and proper monitoring systems to ensure your cleanroom operation's success. With careful planning and attention to detail, constructing a shipping container cleanroom can be a cost-effective and sustainable option for various industries.

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technology is an essential part of many industrial and scientific processes. It provides a controlled environment where the concentration of airborne particles, temperature, humidity, and other environmental factors are carefully regulated to ensure the quality and reliability of products and experimental results. The principle of cleanroom technology is based on the meticulous management of contaminants to prevent their impact on sensitive processes. In this article, we'll explore the principle of cleanroom technology in detail, from the importance of cleanroom design to the methods used to maintain a cleanroom environment.

The Importance of Design

design is crucial in creating an environment that meets the stringent requirements for cleanliness. The design process must consider a wide range of factors, including the layout of the space, airflow patterns, and the materials used in construction. The goal of pharma clean room design is to minimize the introduction, generation, and retention of particles to ensure the cleanliness of the environment.

One of the key elements in cleanroom design is airflow control. The direction and velocity of airflow within the cleanroom are carefully controlled to minimize the spread of particles. Positive pressure systems, where the air pressure inside the cleanroom is higher than the pressure outside, are often used to prevent the entry of contaminants from the surrounding environment.

Another important aspect of cleanroom design is the selection of suitable building materials. The materials used in the construction of cleanrooms must be non-shedding and easy to clean. Wall and ceiling panels, flooring, and doors must all be carefully chosen to minimize the release of particles into the environment.

Proper cleanroom design also involves the implementation of effective filtration systems. High-efficiency particulate air (HEPA) filters and ultra-low penetration air (ULPA) filters are commonly used to remove particles from the air. These filters must be regularly monitored and replaced to maintain their effectiveness in preventing airborne contamination.

Overall, cleanroom design plays a critical role in creating an environment that meets the stringent cleanliness standards required for various industrial and scientific processes.

The Control of Airborne Particles

Airborne particles are a significant concern in cleanroom environments, as they can compromise the quality and reliability of products and experimental results. The control of airborne particles in cleanrooms involves several key strategies, including filtration, airflow control, and personnel gowning.

Filtration is an essential part of particle control in cleanrooms. HEPA and ULPA filters are used to remove particles as small as 0.3 microns from the air, helping to maintain the cleanliness of the environment. These filters are typically installed in the ventilation system and air handling units to ensure that the air entering the cleanroom is free from contaminants.

Airflow control is another critical factor in the control of airborne particles. Cleanrooms are designed with carefully controlled airflow patterns to minimize the spread of particles within the environment. Unidirectional airflow, where air moves in a single direction, is commonly used to prevent the re-circulation of particles. This airflow pattern helps to maintain a clean and controlled environment for sensitive processes.

Personnel gowning is also an important aspect of particle control in cleanrooms. personnel are required to wear special garments, including coveralls, gloves, and hoods, to prevent the release of particles from their clothing and skin. Gowning procedures must be carefully followed to minimize the introduction of contaminants into the cleanroom environment.

Overall, the control of airborne particles is a critical aspect of cleanroom technology, and it requires careful attention to filtration, airflow control, and personnel gowning to maintain the cleanliness of the environment.

The Role of Environmental Monitoring

Environmental monitoring is an essential part of maintaining the cleanliness and integrity of cleanroom environments. It involves the regular testing and analysis of various parameters, including particle count, temperature, humidity, and air pressure, to ensure that the environment meets the required standards.

Particle count monitoring is a crucial aspect of environmental monitoring in cleanrooms. Particles in the air are measured using particle counters, which detect and count particles of various sizes. The results of particle count monitoring help to assess the cleanliness of the environment and identify any potential sources of contamination.

Temperature and humidity monitoring are also important in cleanroom environments. These parameters must be carefully controlled to ensure the stability of processes and the comfort of personnel working in the cleanroom. Regular monitoring and adjustment of temperature and humidity levels are essential to maintaining a controlled environment.

Air pressure monitoring is another critical aspect of environmental monitoring in cleanrooms. Positive pressure systems are commonly used to prevent the entry of contaminants from outside the cleanroom, and these systems must be carefully monitored to ensure their effectiveness in maintaining a clean environment.

Overall, environmental monitoring is a key part of cleanroom technology, and it requires regular testing and analysis of various parameters to ensure the cleanliness and integrity of the environment.

Maintenance of Practices

Maintaining the cleanliness and integrity of cleanroom environments requires strict adherence to a range of practices and procedures. personnel must follow specific protocols for gowning, behavior, and equipment usage to prevent the introduction of contaminants into the environment.

Gowning procedures are a critical part of maintaining cleanroom practices. Personnel must follow strict protocols for donning and doffing cleanroom garments to prevent the release of particles from their clothing and skin. Gowning areas are typically provided to facilitate these procedures and minimize the risk of contamination.

Behavioral practices are also essential for maintaining the cleanliness of cleanroom environments. Personnel must be trained to minimize unnecessary movements and actions that could generate or release particles. Proper behavior, such as avoiding sudden movements and not touching surfaces unnecessarily, helps to maintain the integrity of the environment.

usage protocols are another important aspect of cleanroom practices. used in cleanroom environments must be carefully maintained and cleaned to prevent the release of particles. Regular inspections and cleaning schedules are essential for ensuring the cleanliness and reliability of pharma machinery used in sensitive processes.

In summary, the maintenance of cleanroom practices requires strict adherence to gowning procedures, behavioral practices, and equipment usage protocols to prevent the introduction of contaminants into the environment.

Summary

technology is a critical part of many industrial and scientific processes, providing a controlled environment where the cleanliness and integrity of the environment are carefully regulated. The principle of cleanroom technology involves the meticulous management of contaminants to ensure the quality and reliability of products and experimental results. Factors such as pharma clean room design, the control of airborne particles, environmental monitoring, and the maintenance of cleanroom practices all play essential roles in maintaining the cleanliness and integrity of pharma clean room environments. By understanding and implementing these principles, industries and scientific research organizations can ensure the success and reliability of their processes and results.

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