Medicines are special commodities that are related to people's life safety.

Chapter 2 of the 2010 revised appendix of GMP states: "The production of sterile drugs must strictly follow carefully designed and validated methods and procedures, and the sterility or other quality characteristics of the product must not rely on any form of final processing or finished product inspection (including sterility testing). Obviously, process control becomes particularly crucial and important for overall risk control.

The safety of drug production is actually about avoiding contamination and bacterial infection. Usually, there are three main sources of pollution: personnel, environment, and process equipment. Today, we will talk about personnel and environment.

I believe everyone knows that people are the biggest source of pollution in the clean room environment, as personnel are involved in almost all production steps, and their level of activity will directly affect the environmental quality of the entire clean room. The pollution caused by operators in the sterile room will account for 95% of the total pollution causes.

Research has shown that the bacterial count of clean room workers wearing sterile clothing is as follows:

Static state: 10-300 per person per minute

General activity status: 150-1000 per person per minute

Fast walking state: 900 to 2500 per person per minute

Coughing once: 70-700 per person per minute

Sneezing once: 4000 to 62000 per person per minute

An organization collected samples of microbial contamination in the core production area (i.e. dynamic A/B or A/C level) environment of a sterile drug production enterprise in a specific area. A total of 265 microbial isolates were collected, and 63 microbial isolates were collected in * area, accounting for 23.8% of the total number of contaminated microorganisms. There are many and complex types of microbial pollutants in * area. The degree of air microbial contamination decreases from lower to higher levels in areas of different cleanliness levels, but the difference in surface microbial contamination levels between different cleanliness levels is not significant.

This indicates that air purification and physical isolation can effectively block the spread of most microorganisms, butPollution caused by contact and operation remains the main problem faced by production enterprisesAccording to a study by the European Commission for Medicinal Products (CVMP), the biggest flaw in sterile pharmaceuticals in the United States in 2016 was "microbial contamination," with the fourth being skin exposure during the use of unsterilized personal protective products and ingredients. At the same time, the incidence of warnings due to personal contamination has been increasing in FDA Warning Letters in the past two years.

Therefore, it is urgent to reduce the probability of pollution, control the production risks of sterile enterprises, and reduce costs, especially for the control and improvement of personnel in the largest pollution sources. This is a crucial part of ensuring drug safety and life safety.

Using Cole Parmer's newly launched ThinTouch SteriClean sterile latex gloves for the pharmaceutical industry can effectively provide safe and sterile protection. It is comfortable and flexible to wear, and provides stable and consistent cleanliness control. It uses gamma irradiation sterilization and undergoes low protein testing to minimize allergic reactions.

Our products are designed and manufactured strictly in accordance with pharmaceutical industry standards, with 3 layers of clean packaging, and comply with GMP wearable standards. Meanwhile, it also undergoes ion and non-volatile residue testing to ensure compliance with cleanroom standards.

In addition, the packaging bag of each pair of gloves is printed with complete product information, item number identification, size, batch number, and other information, which can prevent users from accidentally handling the wrong product.

Product Features

• Gamma irradiation sterilization

• The packaging environment meets the level 10 cleanliness standard

• Design and manufacture strictly in accordance with pharmaceutical industry standards

• Three layer clean packaging, compliant with GMP wearable standards

• AQL* 0.65 Level 3

• Low protein, low endotoxin content

• The puncture resistance and durability of

• Hemp clean design, sensitive touch, enhances grip strength

• Available lengths: 12 "and 16"