When it comes to determining the style of class 7 cleanroom , SUZHOU PHARMA MACHINERY CO.,LTD. involves the quality, style, features, trademarks, and packaging into the design. In order to meet a certain demand of the target market and gain a high level of customer satisfaction, we make decisions on the level of product quality by constantly improving product quality and gradually enriching product functions. We also continuously develop new products, improve technology and equipment technology content, and constantly reduce costs to provide a much better product to our old and new customer, so as to maintain a higher market share and investment rate of return. And we improve the style of class 7 cleanroom in some degrees in accordance with the customers’ requirements, which can add our products’ distinguishing features.

With outstanding quality of industrial clean room, SZ PHARMA MACHINERY leads the cleanroom project market development and has created industry benchmarks. SZ PHARMA MACHINERY produces a number of different product series, including class 7 cleanroom . Before delivery, the quality assurance testing of SZ PHARMA MACHINERY class 7 cleanroom must be completed. It is ensured a better performance during start-up and commissioning. To guarantee quality of this product, our quality check team strictly implements measures of testing.

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Clean rooms, also known as air-clean rooms or sterile environments, are designed to minimize contamination by controlling the flow of air, surfaces, and materials into and out of the room. These controlled environments are essential in industries such as electronics manufacturing, pharmaceuticals, and food processing, where maintaining a high level of cleanliness and hygiene is crucial for product quality and consumer safety. There are two main types of clean rooms: Grade B and Grade C. In this blog, we will explore the key differences between these two types of clean rooms.

 

Grade B Clean Rooms

 

A Grade B cleanroom is designed for applications that require a moderate level of cleanliness and protection against microorganisms. These rooms typically have a filtering efficiency of 95% to 99.97%, which means they can remove up to 95% of airborne particles as small as 0.3 microns (a micron is one millionth of a meter). A Grade B clean room is suitable for applications such as semiconductor fabrication, chemical processing, and medical device manufacturing.

 

Key features of a Grade B clean room include:

 

1. High-efficiency filtration systems: The filtration system is responsible for removing contaminants from the air. This can be achieved through various methods, including HEPA (high-efficiency particulate air) filters, activated carbon filters, and ultraviolet (UV) light systems.

 

2. Adequately sealed windows and doors: To maintain the integrity of the clean room environment, all doors and windows must be properly sealed to prevent external contamination from entering the room.

 

3. Robust partitions: Clean room partitions should be designed to withstand frequent cleaning and maintenance without compromising the overall cleanliness of the environment.

 

4. Ventilation systems: Proper ventilation is essential to ensure that the air in the clean room remains fresh and free from contaminants. This can be achieved through a combination of mechanical ventilation systems and natural ventilation methods such as opening windows or using exhaust fans.

Grade C Clean Rooms

 

A Grade C clean room is designed for applications that require the highest level of cleanliness and protection against microorganisms. These rooms are suitable for applications such as nuclear waste management, radioactive material handling, and pharmaceutical manufacturing.

 

Key features of a Grade C clean room include:

 

1. Ultra-high-efficiency filtration systems: Grade C clean rooms often use advanced filtration systems that can remove even smaller particles, down to 0.1 microns or less. This level of filtering efficiency ensures that the room remains highly contamination-free.

 

2. Advanced monitoring systems: To maintain the integrity of the clean room environment, advanced monitoring systems are used to track air quality parameters such as temperature, humidity, and particle concentration. These systems can alert operators to any deviations from optimal conditions, allowing for prompt corrective action.

 

3. Specialized equipment: As the level of cleanliness required for Grade C applications is very high, specialized equipment such as radiation shielding, anti-static flooring, and specialized lighting may be required to create an effective clean room environment.

 

In conclusion, both Grade B and Grade C cleanrooms are designed to provide a controlled environment that minimizes contamination. However, the key difference lies in the level of cleanliness and protection required for each application. While Grade B clean rooms are suitable for applications that require a moderate level of cleanliness, Grade C cleanrooms are necessary for applications that demand the highest levels of protection against microorganisms and other contaminants.

 

 

Suzhou Pharma Machinery Co.,Ltd.

2023/10/24

Mia

Requirements for tablet pressing equipment in clean room workshop?

The clean room tablet press is divided into single punch tablet and rotary tablet according to the number of punches, and can be divided into circular tablet tablet and guide tablet tablet according to the shape of the tablet to be pressed; the core of the single punch tablet The structure is composed of die ring, upper punch, lower punch, three regulators and a hopper that can move left and right,...
Text label: clean room tablet pressing equipment, clean room equipment requirements, clean room design, installation and construction

Requirements for tableting equipment in a clean clean room modular workshop?


The clean room tablet press is divided into single punch tablet and rotary tablet according to the number of punches, and can be divided into circular tablet tablet and guide tablet tablet according to the shape of the tablet to be pressed; the core of the single punch tablet The structure is composed of a die ring, an upper punch, a lower punch, three regulators and a hopper that can move left and right. With the help of an eccentric wheel and a cam mechanism, filling, tableting, tableting, etc. are completed within one rotation of the inertia wheel. Rotary tablet presses are widely used in tablet production, a turntable with three layers of raised edges is fixed on the vertical spindle of the rotary tablet press, and the three layers of raised edges are successively pressed from top to bottom. It is called the upper punching plate, the die plate and the lower punching plate. The same number of holes are evenly distributed on the circumference of the convex edge of each layer at a certain distance from the center line of the vertical spindle. a vertical line.


In order to make full use of the space of the die plate and improve the production capacity of the tablet press, the rotary tablet press is mostly designed as a double-press type. It becomes two cycles; there are two sets of pressing wheels in the double-pressing tablet press. In order to reduce the vibration and noise of the machine, two sets of pressing rollers are used to press alternately, so the number of punches of the rotary tablet press is mostly odd; there are many punching dies. It is made of bearings with high strength, hardness and wear resistance, and should have a high smoothness. The die should have good interchangeability. The size of the die hole is precisely matched with the punch, so that the punch is in the die hole. Can go up and down freely, the tolerance between punch and die hole is ≤0.06mm, and the tolerance of punch length is ≤0.1mm. In order to maintain the accuracy of punch and middle die, collision should be avoided when using, and punch and middle die should be stored in the counter when not in use In order to improve the adjustment accuracy, the worm gear and worm mechanism are used in each adjustment device; in order to prevent the friction between the feeder and the die plate, the distance between the bottom of the feeder and the die plate should be kept 0.03-0.1mm. Ordinary rotary tablet press has a small diameter of the turntable and a large bottom area of u200bu200bthe punch, although it is beneficial to the forming of the tablet, but the number of fillings is small, and the number of tablets per unit time is small. The friction increases; the increase in the number of pressure rollers will increase the area occupied by the equipment, so a secondary compression tablet press with two sets of pressure rollers with the same diameter is usually used instead of a tertiary compression tablet press. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and purification plants.














The clean clean room modular tablet press bears a lot of force when pressing the tablet. In order to prevent damage to the machine parts and the die, when pressing ordinary viscous powder, the speed of the tablet press should generally be ≤50r/min. The friction force of the punching die is large, and the rotation speed should be ≤40r/min. In order to improve the stress condition of the tablet press, an inclined pressing wheel tablet pressing machine is developed. The trajectory of the point is a complex curve. The quality of the tablets produced by the inclined wheel tablet press is better, and when the rotation speed is much higher than that of the ordinary tablet press, the damage to the punch and the middle die is far less than that of the ordinary tablet press. machine. The powder filling time of ordinary rotary tablet presses accounts for about 42% of the total operating cycle. The use of forced powder filling to shorten the filling time can reduce the diameter of the die plate and improve the production capacity of the tablet press.
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Cleanrooms are specialized environments designed to keep contamination at a minimum. They are used in various industries, such as pharmaceutical, electronics, and aerospace. Creating a cleanroom involves using specialized pharma machinery, procedures, and materials, many of which should be selected with great care to ensure that they do not contribute to contamination.

The materials used in a cleanroom should meet strict specifications for cleanliness, particulate generation, and chemical composition. Here are some of the commonly used materials in cleanrooms.

1. Flooring materials

The floor of a cleanroom is an important factor in maintaining cleanliness. The flooring material must be resistant to chemicals, moisture, and abrasion. Common materials used in pharma clean room floors include vinyl sheets, static-dissipative materials, and epoxy resin coatings.

2. Wall coatings

The walls of a cleanroom should have a smooth, flat surface to prevent the accumulation of contaminants. The wall coatings should resist chemicals and be easy to clean. Coatings made of epoxy, polyurethane, or acrylic materials are commonly used in cleanrooms.

3. Ceiling tiles

Ceiling tiles should be designed for cleanroom requirements, including resistance to moisture, dust, and bacteria. The tiles must have a smooth surface and be non-porous, so they don't absorb moisture which can cause mold or mildew. The most common materials used for cleanroom ceiling tiles are vinyl-coated gypsum, fiberglass-reinforced plastic, and steel.

4. Filters

Filters are an essential element in cleanrooms, as they remove particles from the air. HEPA (High Efficiency Particulate Air) filters are the most commonly used in cleanrooms. HEPA filters can remove particles as small as 0.3 microns with an efficiency rate of 99.97%.

5. Gloves

Gloves are an important part of maintaining cleanliness in a cleanroom. They protect the product and the operator from contamination. The gloves used in a cleanroom should be made of materials that do not shed particles or contain chemical contaminants. Some commonly used materials for gloves include latex, nitrile, and neoprene.

6. Wipes and Swabs

wipes and swabs are used to clean surfaces and pharma machinery in the cleanroom. These products must be free of particles, fibers, and other contaminants. Wipes can be made of various materials, such as polyester, polypropylene, or cellulose-based materials. Swabs may be composed of rayon, cotton, or polyester material.

7. Protective Clothing

operators must wear specialized clothing to minimize the amount of particles they emit. This protective clothing should be made of materials that do not add contaminants to the environment. Common materials used include disposable Tyvek suits, polyester, and polypropylene clothing.

Cleanrooms are an essential element in many industries that require a sterile, particle-free environment. The materials used in these environments must be carefully selected and specified to meet strict cleanroom regulations. Each element of the cleanroom- flooring, wall coatings, ceiling tiles, gloves, swabs, etc.- plays a role in maintaining cleanliness and minimizing contaminants. By selecting the right materials, it is possible to create a cleanroom that meets the most stringent standards while also being cost-effective.

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The pharmaceutical industry is highly regulated to ensure the safety and efficacy of medications. One crucial aspect of pharmaceutical manufacturing and storage is maintaining a clean and controlled environment. Cleanrooms are specially designed spaces that adhere to specific cleanliness standards to minimize the risk of contamination. In the pharmaceutical sector, the International Organization for Standardization (ISO) has set guidelines for cleanroom standards, with ISO 8 being one of the most commonly implemented levels. In this article, we will delve into the understanding and implementation of ISO 8 standards in pharmacies, highlighting its importance and providing practical insights to achieve compliance.

The Significance of ISO 8 Standards

Cleanrooms play a vital role in the pharmaceutical industry by providing a controlled environment where the risk of contamination is minimized, ensuring the quality and purity of medications. ISO 8 is the standard classification for cleanrooms that have a permissible particle count of no more than 3,520,000 particles per cubic meter. While ISO 8 is less stringent compared to higher classifications like ISO 7 or ISO 6, it is still crucial for pharmacies to comply with these standards to maintain the integrity of their products.

Complying with ISO 8 standards ensures that pharmacies meet the necessary regulatory requirements and Good Manufacturing Practices (GMP). These standards help prevent cross-contamination, reduce the risk of product spoilage, and ultimately safeguard patient health. By implementing ISO 8 standards, pharmacies can improve the quality of their medications, enhance customer trust, and mitigate the potential risks associated with inferior manufacturing or storage conditions.

Designing a to Meet ISO 8 Standards

Creating a cleanroom that meets ISO 8 standards requires careful planning and implementation. Here are some essential factors to consider:

HVAC System and Air Filtration

An effective heating, ventilation, and air conditioning (HVAC) system is imperative for maintaining the cleanliness of a cleanroom. Proper air filtration is necessary for removing airborne particles and maintaining the desired air quality. ISO 8 cleanrooms typically require HEPA (High-Efficiency Particulate Air) filters to achieve the desired particle count. The HVAC system should be designed to provide adequate air changes per hour (ACH) to ensure continuous air purification and minimize particle buildup.

Surface Materials and Finishes

The selection of surface materials and finishes in a cleanroom is crucial to prevent particle generation and microbial growth. Smooth and non-porous materials are preferred as they can be easily cleaned and disinfected. Walls, ceiling, and floors should be constructed using materials that are resistant to chemicals and easy to maintain. These materials should be free from substances that can contaminate the cleanroom environment.

Controlled Access and Gowning Procedures

To maintain a hygienic environment, it is important to control access to the cleanroom. Only authorized personnel should be granted access, and thorough gowning procedures should be in place. Gowning typically involves wearing cleanroom apparel such as coveralls, gloves, hair covers, boots, and face masks. Proper gowning procedures help prevent human contamination and ensure compliance with ISO 8 standards.

Environmental Monitoring

Regular environmental monitoring is essential to validate the effectiveness of the cleanroom and ensure ongoing compliance with ISO 8 standards. This involves conducting particle count measurements, air pressure differentials, temperature, humidity, and microbial monitoring. Monitoring data helps identify any areas for improvement and ensures the cleanroom remains within specified limits.

Cleaning and Disinfection

Routine cleaning and disinfection are vital to maintain a clean and sterile environment. personnel should follow standard operating procedures (SOPs) for cleaning and disinfection. Dedicated cleaning agents and disinfectants approved for cleanroom use should be used to minimize the risk of residue or particle generation. Cleaning frequency and methods should be documented and strictly followed to meet ISO 8 standards.

In Summary

Implementing ISO 8 standards in pharmacies is crucial for maintaining the integrity and quality of medications. Compliance with these standards ensures a controlled environment, minimizes the risk of contamination, and complies with regulatory requirements. Designing a pharma clean room to meet ISO 8 standards involves considerations such as HVAC systems, surface materials, controlled access, environmental monitoring, and cleaning procedures. Regular audits and monitoring are necessary to evaluate and validate the effectiveness of the pharma clean room. By adhering to these standards, pharmacies can ensure patient safety, foster trust in their products, and contribute to the overall quality of the pharmaceutical industry. So, embrace ISO 8 standards and create a clean and controlled environment within your pharmacy to provide the highest quality medications to your patients.

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