What is GMP cleaner?
GMP cleaner definition
is a laboratory cleaning machine that meets good manufacturing practice and is mainly used for cleaning process instruments and containers, GMP cleaner is often a cleaning machine that can meet the cleaning of the inner wall of glassware and fine crevices, small holes, and dead ends.
Information about GMP
stands for GOOD MANUFACTURING PRACTICE
, which is defined by the World Health Organization as a regulation that guides the production and quality management of food, drugs, and medical products.
GMP is an autonomous management system that pays special attention to product quality and health and safety in the manufacturing process, and GMP certification is the embodiment of total quality management in the pharmaceutical industry. It is a set of mandatory standards for the pharmaceutical, food, and other industries, requiring enterprises to meet the health and quality requirements in terms of raw materials, personnel, production processes, packaging and transportation, quality control, etc. by relevant national regulations, forming a set of operational specifications to help enterprises improve their health environment and identify problems in the production process promptly for improvement.
Application of GMP cleaner
GMP cleaner has the characteristics of safety, high efficiency, time saving and simple operation, avoiding direct contact of staff with instruments, no splashing of sewage in washing, ensuring the safety of staff.
In recent years, the popularity and development of integrated management mode of supply room, in order to reduce human resource consumption and improve the quality and efficiency of instrument cleaning, the cleaning of a large number of contaminated surgical instruments and therapeutic instruments is mainly done by GMP cleaning machine. After the instruments are contaminated by blood, pus and other body fluids, if the cleaning is not complete, biofilm is easily formed, which affects the penetration and killing effect of chemical disinfectants and high-pressure steam, and increases the resistance of microorganisms to heat, resulting in sterilization failure.
GMP cleaning machine using multi-enzyme cleaning solution can effectively decompose various organic secretions at high speed, i.e. decompose protein, mucopolysaccharide, fat and sugar, and reduce surface tension; it can increase the microorganisms removed from the surface of objects when cleaning. The multi-enzyme solution can enter the deep part of the lumen and penetrate all surfaces of the lumen, reducing the surface bioburden of the object by 3-5 log levels. It has been reported in the literature that conventional cleaning methods are ineffective for instruments with blood stains that have turned in, and that multi-enzyme solution cleaning is superior to water and chlorinated disinfectants in the moisturizing treatment of instruments. Soaking with enzymes before cleaning can make the instruments in a moisturized state, thus improving the quality of cleaning.
GMP cleaner structure
1. Control System
The GMP cleaner can memorize up to 10 fully programmable process cycles according to user requirements and 20 fully programmable process cycles according to user needs. The number of cycle stages, temperature, cleaning agent addition, feed source and other key process parameters can also be programmed.
2. Circulation System
Adopt energy-efficient circulation pump to eliminate residual chemicals, adopt double-circulation pump design to distribute water more evenly, and have soft-start control to prevent the vessel from being shocked at the moment of pump start.
3. Piping system
The circulating pipeline is equipped with two pressure monitoring systems, which will suspend the operation of the circulating pump when the cleaning water pressure is abnormal. The water flow meter is built into the pipeline to calculate the water intake in real time; the inner cavity water tank is equipped with low and high liquid level alarm devices to provide security for the cleaning water.
4. Safety protection system
Water heating over-temperature protection, hot air heating over-temperature protection, water pump over-temperature protection, fan over-temperature protection.
5. Drying system
Double-compressed fan drying system, dry air through the injection cleaning racks directly to the inside of the vessel.
Advantages of using GMP cleaner
1. GMP cleaner can avoid cleaning laboratory operators to directly contact the contaminated glassware, avoiding harmful viruses, bacteria and other health threats to cleaning personnel. It can save the time of cleaning glassware for laboratory operators, improve the efficiency and save the cost for users.
2. With high temperature heating disinfection function, in line with national standards.
3. Make the laboratory cleaning is traceable, there are cleaning procedures to follow, with good traceability, cleaning is completed can automatically print the experimental data.
4. Take the automatic cleaning, automatic rinsing, automatic drying, no secondary pollution. The cleanliness of the cleaned vessels is more uniform and the cleanliness is high.
5. Organic solvents and other washing solutions can be avoided to the health of the washer, but also to avoid its pollution of the environment. Can easily clean the buret, pipette, volumetric flask, distiller and other special-shaped instruments.
6. With the scientific and intelligent cleaning method, the cleaning agent, water and electricity resources and other related expenses of the laboratory can be saved and the impact on the environment can be reduced, thus achieving low consumption and environmental protection.
7. Glassware fragile, such as impact, drop, squeeze, rapid temperature changes, etc., which may harm the use of laboratory personnel, cleaning machine can effectively avoid such problems.
GMP cleaner specifications and features
Large GMP cleaner
|Housing material||304 stainless steel
|Inner cavity material|| 316L stainless steel
|Opening mode|| single door / double door
|Inner cavity volume||688L
Large GMP cleaner is used to clean critical components of special cleaning systems such as fermentation tanks, large balloon bottles, large glassware, filling and packaging machine components, mixers, funnels, trays, boxes, tablet press tools and other items used in the production of pharmaceuticals, diagnostics, cosmetics and food products.
1. Large GMP cleaner uses a side opening tempered glass door that allows the operator to observe the interior of the chamber with the door closed; ensures complete air and water tightness of the cleaning chamber by dynamically pressing a silicone
2. Equipped with an emergency stop switch for safe emergency stop.
3. With three levels of management authority, the printer can automatically print cleaning data and export PDF files of cleaning records, operation records and alarm records for inspection.
Stainless steel GMP cleaner
|Washing liquid type|| alkaline detergent main wash, acid detergent neutralizing effect
Stainless steel GMP cleaner can clean containers, filling utensils, glassware, pipes and other working utensils.
1. Stainless steel GMP cleaner adopts high pressure and high flow cleaning, fast and efficient.
2. Full replacement of manual cleaning, recordable, verifiable, repeatable cleaning, high temperature clean hot air fast drying,
Working process of GMP cleaner
GMP cleaner will first remove the impurities with less adhesion inside the feeding vial to complete the pre-cleaning.
Then use the upper and lower spray arms to clean the outer surface of the vial, and the injection nozzle to clean the inner surface of the vial, and then flush by tap water for simple pre-cleaning.
After automatic drainage, the GMP cleaning machine re-feeds water, heated spray cleaning, after reaching a certain temperature into the alkaline cleaning agent for alkaline main washing.
Alkaline main washing is over, GMP cleaning machine automatic drainage, re-enter the water, automatic discharge into the acid neutralizer, and alkaline detergent residue
Through a step or multi-step pure water rinsing, to ensure that the bottle dish is completely cleaned.
After the automatic drainage of the GMP cleaning machine, the bottles and vessels are dried in the same position. When the drying is finished, the automatic door will open automatically to distribute the temperature inside the cavity.
GMP Cleaner in 2019-nCoV vaccine production
Production equipment is one of the main vehicles for pharmaceutical production and a key element for GMP compliance. Therefore, GMP cleaners play a key role in the production of 2019-nCoV vaccine.
A new 2019-nCoV vaccine from the laboratory to the market, need to go through cell culture, virus culture, inactivation, purification, proportioning, canning, packaging seven steps and more detailed links, GMP cleaner is mainly responsible for a variety of culture bottles, transfer bottles, canning and packaging components, various pipelines, adapters, chucks and other components.
Cleaning verification is an important part of pharmaceutical manufacturing management to ensure that contamination is controlled, and the pharmaceutical industry is facing the challenge of large-scale production, with the current huge demand for new vaccines and the need for factories to pursue automation to a new level, GMP cleaning machines can be faster and more standardized to complete the standardized cleaning, there are some pharmaceutical factories many cleaning procedures are manual cleaning. Even if we can try to standardize the manual cleaning process, to record the temperature, time, agitation, volume and other parameters, but these parameters, itself is also a manual record, it is unreliable. The actual cleaning effect and the risk of product residues need to be further controlled and abated, which are the risks of GMP and FDA certification.
Design requirements of GMP cleaner cleaning system
Due to the different GMP cleaner equipment structure layout, parameters, thermal system complexity, the use of cleaning media, and after the accumulation of scale and distribution location of different, the production of GMP cleaning machine cleaning system size, and complexity also vary. Although each equipment cleaning GMP cleaning machine cleaning system is not the same, the design of the cleaning system should meet the following requirements.
1. Provide to the GMP cleaning machine cleaning system in the heat source, water and power should be sufficient and safe, and reliable.
2. The use of circular flow divided cleaning circuit, should strive to each circuit of the media flow rate difference is not too large, well strive to flow through the cleaning surface flow rate uniform. Try to avoid GMP cleaning machine cleaning system in the local area of the city due to the high flow rate and impact corrosion.
3. To ensure the continuous destiny of the cleaning cycle pump, the GMP cleaning machine cleaning system is best to set up a backup pump. Cleaning pumps as far as possible use an acid-resistant pump, which can be used in place of an ordinary water pump, but the use of the pump and the impeller should be painted with an anti-corrosion acid-resistant coating for protection. To ensure a tight shaft seal, it is better to use an external pressurized water seal. The packing should be equipped with oil-infested flexible graphite packing or packing soaked with PTFE, etc.
4. GMP cleaning machine cleaning system strives for simplicity, should avoid dead zones and "blind intestine tube", requires valve arrangement for easy operation, sampling tube and instrument concentration, and easy supervision.
5. GMP cleaning machine cleaning system must have enough sampling points, to be able to accurately remove the cleaning box, into the acid pipe, back to the acid pipe cleaning fluid samples, not in the flow of the most table or water level meter at the sample.
6. The premise of not affecting the cleaning effect should be as simple as possible and facilitate the cleaning operation.
7. Temporary pipes installed in the GMP cleaning machine cleaning system should not have gravel or other debris, the temporary pipes set horizontally. Inclined in the direction of drainage should not be less than 1/200, the weld should not be close to the important equipment, and the diameter of the temporary pipe is chosen to flow less than 5-6 m / s as the principle.
How to order GMP cleaner?
ANTITECK provide lab equipment, lab consumable, manufacturing equipment in life sciences sector.
If you are interested in our GMP cleaner or have any questions, please write an e-mail to firstname.lastname@example.org, we will reply to you as soon as possible.