Sterilization used class A 4 sterility testing isolator glove ports laminar air flow

PVC sterility test isolator.pdf

Sterility testing of pharmaceutical products is required to determine the acceptability of a production lot. It is an essential element of sterilization validation and it must be performed in a manner which avoids the risks of both false positive and false negative results. Sterility testing is one of the most crucial steps in ensuring the safety of your products. The introduction of contaminants through equipment failure and human error can result in false positives.

Product testing within isolated conditions can help to reduce the frequency of false positive results. Consequently, the occurrence of product re-testing and recall is also reduced, saving time, money and materials.

False positive results are generally due to laboratory contamination from the testing environment or from human error. This can cause additional work in terms of additional documentation and cost as it delays or prevents release of the product for sale.

Sterility Test Isolators are designed to protect the product from both the process and externally generated factors that would compromise product quality. Aseptic Containment Isolator (ACTI) and General Processing Platform Isolator (GPPI) have been developed to cover a wide variety of clients' needs in terms of containment solutions.

WINTEAM's new generation of sterility check isolators is a sealed system in which air is safely exchanged through a fan filter unit (High Efficiency Filter, HEPA) to achieve continuous control of particulates and microorganisms in the internal environment. When sealed, the internal surface has been biologically decontaminated. Use rapid transfer channels or air locks for aseptic transfer and transfer of materials to ensure protection between operators and drugs.

2,Parameter

Hard cabin structure consisting of stainless steel + tempered glass;

The ventilation mode is sent to the top row, and the airflow model is engineering turbulence, which greatly reduces the air volume and simplifies the design of the room ventilation system;

The material door is inflated and sealed, with pneumatic locking and working state interlocking function;

Equipped with H14 grade tank sealed high efficiency air filter;

Integrated vaporized hydrogen peroxide sterilization system and YT-601A, YT-608A type aseptic detection system;

Siemens PCL+ touch screen automatic control;

One of the concerns with the sterility test, especially when high-value products are handled, is the risk of false positives that can lead to expensive and lengthy failure investigations (and where proving a false positive is extremely difficult, therefore, the outcome can often be batch rejection). A false positive can be described as a contaminating microorganism that has been transferred into the test media through cross-contamination by personnel or from the test environment; in contrast, to microbial contamination being present in the product under test.

Q: Do all products have English operating interfaces and operating manuals?

A:Yes, all our equipment has English operation interfaces, and if necessary, we are also able to provide the edition in the user's native language, and all products are available in English operating instructions; if necessary, we can also provide the user's desired language version.

In addition, there are are operating videos for our products for the convenience of customers to use.

Q: How is the after-sales service of your company?

A:We offer quality guarantee for all the products, and for products within the warranty period, we provide free services for all damages not resulting from human beings. After the warranty expires, we will charge cost price only

Q: What is your MOQ of the spray dryer?

A:1 set.

Q: How long is your delivery time of spray dryer?

A: Generally it is depending on order quantity.The specific time can be negotiated.

Q: How to choose suitable spray dryer?

A:tell us your work flow and requirements ,then we will recommend you suitable equipment according to yourrequirements, application experience and feedback from our clients.

Q: How to solve the equipment trouble during using ?

A:Please email us about problem with pictures or a small video will be better,we will find the problem and solve it. If broken, we will send you a new free part if in the warranty period.