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The development history of clean operating room
The clean operating room is a place that provides surgery and rescue for patients, and is an important work department that reflects the technical level of the hospital's surgery. After nearly a hundred years of development, the operating room has gradually developed from meeting the needs of surgical operations to maintaining a sterile environment to the maximum extent, reducing trauma infection, and providing...
Text label: clean operating room, sterile operating room, clean operating room development history

Development history of clean operating room


The clean operating room is a place that provides surgery and rescue for patients, and is an important work department that reflects the technical level of the hospital's surgery. After nearly a hundred years of development, the operating clean room modular has gradually developed from meeting the needs of surgical operations to maintaining a sterile environment to the greatest extent possible, reducing trauma infection, and providing a good working environment for medical staff.


The evolution of the operating room


The history of surgery can be traced back to the distant Neolithic Age. With the evolution of the times and the development of society, surgery has developed rapidly, and the development of surgery has led to the development of aseptic methods and disinfection methods. . In the 19th century, anesthesiology was born. In October 1846, the dental department of a general hospital in the United States performed the first major operation under inhalation anesthesia, and the operating room entered the stage of history. Although the venue at that time was located in the classroom of the library, and although no one was wearing standard work clothes, it did open the historical prelude to the development of the operating room. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of GMP workshop, clean operating room, sterile laboratory, purification workshop and other supporting services.


1. Simple operating room (the first generation operating room)


With the development and progress of medicine, in the middle of the 19th century, the invention of anesthesia technology promoted the establishment of surgery and produced the operating room. The development of bacteriology, the development of steam sterilization, the improvement of hand washing in the operating room, the use of masks, the use of surgical gowns, etc., have further promoted the development of surgery.






Second, decentralized operating clean room modular (second-generation operating room)


In the early 20th century, modern surgery was popularized. Each diagnosis and treatment department established its own operating room. The operating room existed in the hospital in a decentralized form. According to the needs of the discipline, the operating room was equipped with corresponding medical treatment. instrument. This decentralized operating room has existed for a long time in the history of operating room development.


Three, centralized operating room (third-generation operating room)


From the end of the 19th century to the beginning of the 20th century, the natural sciences developed rapidly, and the outbreak of the First World War and the Second World War accelerated the reform and improvement of the hospital operating room. Since the mid-20th century, surgery has been further developed, and the operating room has gradually changed from a decentralized form to a centralized form. In 1937, the Universal Exposition held in Paris, France, showcased the centralized operating room, and the modern operating room was officially established. In 1955, the University of Tokyo opened the first operation department, and all specialized operating rooms were centralized and managed in the operation department. In 1963, the centrally-supplied flat-layout operating department was introduced in the United States. This centralized operating system is a revolution in the history of operating room development. Modern operating rooms basically belong to this type.


Four, clean operating room


Today, we have entered a new century, the rapid development of medicine has provided a brand-new medical environment, and the fourth-generation operating room has entered our era. In the 1950s, due to the needs of the microelectronics industry and the precision machinery industry, air cleaning technology was produced. After this new technology came out, it was immediately valued by medical experts and clinical medical engineering experts. In the mid-1960s, Mr. CHARN-LEY, a well-known orthodontic expert at Tinton Hospital in Wiganbo, UK, first applied vertical laminar flow purification technology to surgery, which significantly reduced the number of bacteria in the air. Due to the joint efforts of medical experts and clinical medical engineering technicians, the design of clean air operating room has been gradually improved, and its obvious effect of reducing the infection rate of surgery has been recognized by the society. In 1966, the world's first laminar flow clean operating room was established at Patton Memorial Hospital in the United States. The construction of the operating department has developed into a new stage, that is, the clean operating room stage.
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How to install the fresh air unit in the clean workshop?

Fresh air conditioning unit is mainly composed of air filter, cooling heat exchanger and blower unit. Common fresh air unit air conditioners are vertical, horizontal and ceiling type. Before installation, you should understand its structural characteristics and installation points in detail. ;The ceiling-mounted new ventilation unit air conditioner is hoisted in...
Text label: clean pharmaceutical cleanroom installation, fresh air unit installation

How to install the fresh air unit in the clean workshop?


Fresh air conditioning unit is mainly composed of air filter, cooling heat exchanger and blower unit. Common fresh air unit air conditioners are vertical, horizontal and ceiling type. Before installation, you should understand its structural characteristics and installation points in detail. ; The ceiling-mounted new ventilation unit air conditioner is hoisted on the roof. Considering the load-bearing aspect, the air volume of the unit does not exceed 8000m3/h in general. , and some reach 20000m3/h, but there must be guarantee measures during installation; reasonably choose the diameter of the boom to ensure hanging installation; if the air volume and quality of the unit are not too large, and the vibration of the unit is small , The top of the boom is connected to the roof with expansion bolts, and the bottom of the boom is connected with a screw thread and a rubber vibration damping pad to connect with the hoisting hole. .


When installing the unit, special attention should be paid to the direction of the air inlet and outlet of the unit, the direction of water inlet and outlet, and whether the extraction direction of the filter is correct, etc. When installing the unit, water leakage should be prevented at the connection of the pipeline, and the insulation material of the unit condensate pan should be protected. , do not expose the condensate pan, and pay special attention to protect the connection threads of the inlet and outlet pipes and the condensate pipes, and wrap the sealing material; reasonably consider the vibration of the unit, and take appropriate vibration reduction measures. A vibration damping device has been installed between the blower inside the unit and the bottom frame of the box; if it is a small-sized unit, you can directly connect the boom to the unit's hoisting hole with screws and washers. If it is large, the installation of vibration damping device should be considered; after the unit is installed, it should be adjusted to maintain the level of the unit. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean workshops and clean rooms.














In order to discharge the condensed water smoothly, there should be a certain slope when connecting the condensed water pipe of the unit. When the air supply port of the unit is connected to the air supply pipe, it should be connected by a canvas hose; after the unit is installed, the balance of the operation of the air supply fan should be checked Check whether the fan is running in the correct direction. At the same time, the cooling and heat exchanger should have no leakage, and a water test should be carried out. During the water test, the air should be discharged through the air release valve on the upper part of the cooling and heat exchanger to ensure that the system pressure and The water system is smooth.
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Modern enterprises need clean workshops, which are also called clean rooms or clean rooms. It is the foundation of pollution control. Without a clean pharmaceutical cleanroom, mass production of contamination-sensitive parts is impossible. Within a certain space, the pollutants such as particles, harmful air and bacteria in the air are eliminated, and the indoor temperature, cleanliness, pressure, airflow speed and airflow distribution, noise and vibration, lighting, and static electricity are controlled within a certain range of requirements. engineering discipline. The negative ion air purification system in the clean workshop equipment can reduce the concentration of suspended particulate matter in the air, but it cannot kill bacteria, viruses, or decompose pollutants. Health effects. The clean pharmaceutical cleanroom has multiple procedures from primary filtration to complete purification, which can quickly kill viruses and bacteria in the air in a short time, remove pollution, smoke and odor. The central air-conditioning photocatalytic air purification and sterilizer module of the clean workshop is composed of coated titanium dioxide fine wire filter, primary and medium-efficiency filter, nano-titanium dioxide photocatalytic chamber, intelligent control system and other factors. It is an efficient multi-factor air purifier and disinfector to prevent respiratory infectious diseases, prevent airborne viruses and bacteria, eliminate smoking hazards and degrade indoor pollution. In addition, biochemical laboratories and high-precision nanomaterial production workshops have higher level requirements. The development of clean workshops will be a major direction of future demand. At present, the highest level is the aviation warehouse of aerospace, which basically belongs to level 1, belongs to a special field, and has a relatively small area. At present, it has applications in many industries such as bioengineering, precision manufacturing, medicine and health, electronic information, semiconductors, optoelectronics, aerospace, and automotive spraying.
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Introduction

Maintaining cleanliness in a blister clean room is of utmost importance for industries involved in pharmaceutical, medical device, and cosmetic production. The need for a controlled environment in such facilities cannot be overstated, as even the tiniest particles or contaminants can have severe consequences on product quality and safety. In this article, we will delve into the best practices for maintaining cleanliness in a blister clean room, ensuring that stringent standards and regulations are met to preserve the integrity of the products being manufactured.

The Significance of Cleanliness in a Blister Clean Room

Cleanliness is the foundation upon which successful manufacturing in a blister clean room is built. It involves the meticulous removal or prevention of foreign particles, contaminants, and microbes from the environment. Cleanliness minimizes the risk of contamination and, in turn, ensures the safety and efficacy of the products being produced.

A blister clean room is specifically designed to minimize the introduction, generation, and retention of particles within the manufacturing process. These particles can include dust, hair, lint, fibers, microbes, and other contaminants that may negatively impact the quality of the products. The importance of maintaining cleanliness in a blister clean room cannot be emphasized enough, as not only does it protect the end-users, but it also safeguards the reputation of the manufacturing company.

Effective Air Filtration Systems

A crucial aspect of cleanliness in a blister clean room is the implementation of an effective air filtration system. The air quality within the clean room plays a pivotal role in maintaining cleanliness standards. It should be devoid of particles, contaminants, and microorganisms.

High-efficiency particulate air (HEPA) filters are widely used in blister clean rooms. These filters are capable of removing particles as small as 0.3 microns with an efficiency of 99.97%. The air handling system should be properly designed to ensure adequate air changes per hour (ACH), maintaining a clean, controlled environment. Regular monitoring and maintenance of the air filtration system are vital to ensure its optimal efficiency.

The positioning of HEPA filters, airflow patterns, and proper use of airlocks are some considerations that contribute to effective air filtration. By establishing positive air pressure within the clean room, contaminants from outside are prevented from entering. Filtering the air effectively reduces the risk of contamination and ensures the cleanliness required for blister packaging.

Strict Gowning Procedures

To maintain cleanliness standards in a blister clean room, stringent gowning procedures must be followed by personnel entering the facility. Gowning serves as a protective barrier, preventing the introduction of contaminants and particles from the operators themselves.

Cleanroom garments, including coveralls, hoods, gloves, and shoe covers, play a crucial role in gowning. The material of these garments should be non-shedding and designed to minimize the release of particles. Personnel must be trained on the proper gowning techniques, including the correct order of donning and doffing garments. This ensures that contamination risks are minimized during the gowning process.

Additionally, thorough cleaning and disinfection of the hands using approved methods, such as alcohol-based sanitizers, are vital before donning gloves. The appropriate use of personal protective equipment (PPE) helps create a barrier between the operators and the clean room environment, preserving its cleanliness.

Routine Cleaning and Disinfection Protocols

Routine cleaning and disinfection protocols are essential for maintaining cleanliness in a blister clean room. These protocols should be comprehensive, covering all aspects of the clean room, including surfaces, equipment, tools, and storage areas.

Cleaning agents and disinfectants approved for use in clean rooms should be selected and used according to the manufacturer's instructions. It is vital to ensure that the cleaning and disinfection agents not only effectively remove contaminants but also do not leave any residues or harmful byproducts behind.

Surfaces should be cleaned regularly, paying attention to high-touch areas. This may include workbenches, pharma machinery surfaces, countertops, and handles. The cleaning process should involve a two-step approach: pre-cleaning to remove visible debris and then disinfection to kill microorganisms.

It is equally important to have a robust cleaning validation program in place to ensure the efficacy of the cleaning process. Regular monitoring, testing, and documentation of cleaning procedures will provide assurance that the cleanliness standards are being met consistently.

Proper Waste Management

Proper waste management is integral to maintaining cleanliness in a blister clean room. All waste generated during the manufacturing process should be handled, segregated, and disposed of appropriately. Failure to manage waste effectively can lead to cross-contamination and compromise the cleanliness of the clean room.

Segregation of waste is essential to prevent contamination and ensure proper disposal. Different types of waste, such as general waste, hazardous waste, recyclable waste, and biohazard waste, should be segregated using clearly labeled containers. Waste containers should be located strategically within the clean room, promoting easy access and reducing the risk of spills or mishandling.

Waste disposal should comply with regulatory requirements and industry standards. It is vital to have a waste management plan in place, in coordination with authorized waste disposal agencies. Regular audits and inspections should be conducted to verify compliance with waste management protocols, ensuring the cleanliness and safety of the blister clean room environment.

Conclusion

Maintaining cleanliness in a blister clean room is paramount to the successful production of pharmaceutical, medical device, and cosmetic products. By implementing effective air filtration systems, strict gowning procedures, routine cleaning and disinfection protocols, and proper waste management, industries can ensure that their products meet stringent quality and safety standards.

A blister clean room should adhere to guidelines and regulations specific to the industry it serves, whether it be pharmaceuticals, medical devices, or cosmetics. It is essential for companies to invest in training and educating personnel on the importance of cleanliness and the proper implementation of practices.

By prioritizing cleanliness, industries can not only safeguard the health and well-being of their end-users but also protect their own reputation and market standing. Proper cleanliness practices not only contribute to a cleaner manufacturing environment but also foster trust and confidence in the quality and safety of the products being produced.

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