Skilled in measuring, into the micro: new gen biological visa together hand in hand, to provide high standard virus cleaning process validation service
In recent years, as people increasingly attention to life health issues as well as in social and public health under the catalysis of multiple factors, such as a wide variety of biological products more and more into our daily life.However, biological products production process is complex, faced with multiple risks, including contaminated the validation of the guarantee of safety and effectiveness are becoming ever more important.
As approved by the hangzhou market supervision and administration of the establishment of independent third party inspection agencies, hangzhou new gen biological detection co., LTD. (hereinafter referred to as the "new", ") focus on virus cleaning process validation, but in the different stages of biological products research and development, providing customers with virus cleaning process validation of safety.Through close cooperation with visa to pull, new biological environment detection accuracy and system stability reach even exceed industry standards, process validation service for the domestic well-known pharmaceutical companies successful.
Preventive biological pharmaceutical industry "gatekeeper"
With type of biological products is various, and the use of increasingly population growing, the government and relevant institutions at home and abroad puts forward higher requirements on the safety of biological products, also set up the corresponding threshold.Among them, the biological pharmaceutical clinical trial Application (" Investigational New Drug ", hereinafter referred to as the "IND") and New Drug applications (namely "Biologic License Application", hereinafter referred to as the "BLA") is the key to the corresponding phase milestone.
"Before the biological products in clinical trials and listed, must carry out virus cleaning process validation, to prove its production process have the ability to intercept and inactivated virus."New gen biological head ShenDeJin said: "the new gen biological for biological pharmaceutical industry clients with process validation independent third-party agencies, to provide customers with customized IND, BLA stage authentication service, at the same time can provide the Chinese and foreign scheme and bilingual report."
Unlike traditional industrial products manufacturing, biological pharmaceutical industry is demanding to the safety of the product requirement, and as the key industry "gatekeeper", new biological preventive, plan ahead, with higher standard security verification process the conditions required.
In April 2020, the new biological investment more than 5000 ten thousand yuan, according to the technical specification for construction of biosafety laboratories (GB 50346-2004) established a high standard of BSL - 2 + laboratory, equipped with cells in the laboratory, virus lab, multi-functional laboratory, multiple functions such as molecular biology laboratory units, have verified the international mainstream of various kinds of testing equipment more than 200 Taiwan (sets), which includes visa pull viewLinc continuous monitoring system, may carry on the real-time online monitoring of the laboratory environment, to meet the needs of all kinds of testing.
So far, the new gen creature has CMA (inspection certificate of qualification examination organization) aptitude and CNAS (conformity assessment of China national accreditation council) laboratory site assessment for approval, at the same time support running multiple independent verification of the project.Founded just 3 years of enterprise, as a new and biological produce economic benefits in 2022 reached 20 million yuan.
The accurate monitoring of soft and hard combined with special environment
Biological pharmaceutical is a have special request for the security industry, new and biological industry as an important gatekeepers, need to a higher standard to request itself, the higher request is through the "hardware" and "software" two aspects to the visa.
In the aspect of hardware,Visa pull viewLinc continuous monitoring systemMeasurement precision is not only meet the industry standards, further satisfy the criteria for the new gen creatures, even higher.
"We more stringent measurement accuracy requirements of temperature and humidity and carbon dioxide, in order to ensure testing experimental high-standard and complete."About visa to pull the product accuracy of measurement, ShenDeJin impressed: "visa to pull the various parameters of the probe performance is satisfactory accuracy, reach or exceed industry all kinds of standards."
Visa pull viewLinc continuous monitoring systemWith a variety of models of data recorder, transmitter and Modbus device integration to monitor multiple parameters: temperature, relative humidity, carbon dioxide and pressure.When the viewLinc andVisa HMP3 intelligent humidity and temperature probeUsed, the temperature accuracy up to + / - 0.1 ℃ (0.18 ℉), relative humidity (RH) accuracy up to 0.8% RH.If withCarbon dioxide transmitter GMD110Cooperate, when using co2 measurement precision can be up to + 40 PPM (forty over one million).
In addition, it is worth mentioning that with the aid of viewLinc, users can easily realization of thousands of monitoring parameters measured at the same time, it provides new and future development of the application of more possibilities.
In ShenDeJin point of view, in addition to visa is almost pull products "standard" with high accuracy, stability of hardware is new and choose one of the main reasons for visa to pull."During the two years of use, visa to pull the product performance is stable, even in the case of power, also can well log data."
On software, visa viewLinc continuous monitoring system is also fully considered the actual needs of users, can be used for real-time monitoring of temperature, humidity and other parameters and alarm, but also from a sensing device extension to thousands of devices and the related data and alarm records will automatic safety placed in system on the server.After successfully applied in New York and biological laboratories, ShenDeJin commented: "visa to pull the product function block open degree is high, friendly interface, convenient data to be obtained, is a personal design."
Laboratory online in the same period, ShenDeJin also tried other similar products."Compared with competing products, visa product precision and sensitivity, higher requirements for the power supply is not high, the stability is better, and do not need artificial auxiliary records."He concluded.
Fast response beyond expectations sincerity service
The origin and development of new gen biological and visa began an investigation.
"As early as 2015, when we examine other third party testing institutions, the first time I heard visa brand, and easy to understand the visa related products."After five years, when ShenDeJin team in 2020 to set up their own process validation lab, he first thought on continuous monitoring system for product purchase a visa.
Then, the two sides from formal contacts, in July 2020 to January 2021 confirm the purchase, details of the project is completed in March to the communication - everything seems to be logical.
"In terms of professionalism or timeliness, visa team provides us beyond expectations, almost impeccable service."ShenDeJin particularly praised the visa service team: "from the early for the introduction of services and equipment configuration to late order status updates, both sides has carried on the positive, the real-time and effective communication."
He said, both in equipment installation and use, visa can timely response and timely, basic service personnel "to" the next day.Especially late during equipment expansion, visa cooperate actively, and all the process is very smooth and efficient.Finally, visa in short period of time than expected to complete the installation and debugging, for new and paved the way for the implementation of the follow-up projects.
In the future, as the biological products production process is complicated, will go with audit requirements, more and more strict.ShenDeJin said, in the face of increasingly stringent audit requirements, adhere to the same high standards and strict new gen biological and visa, the future will have more cooperation opportunities, in both technical and policy, driven by common usher in a new development opportunity, boost the high quality of the whole industry development.
