INDUSTRY INSIGHT

Cleanroom Gloves

—————————————————————————————————————————————

Proper selection and usage of gloves in cleanrooms is an important component of cleanroom hygiene. Appropriate labeling by glove manufacturers can help in right choice by the cleanroom personnel.

—————————————————————————————————————————————

In unclean manufacturing environments, gloves are typically worn to protect the wearer from hazards such as chemicals, extreme heat/cold, and rough or sharp surfaces that could cause hand abrasions. On the other hand, in clean manufacturing settings such as cleanrooms and other controlled environments, gloves are worn to protect the products or processes from contamination and are used along with cleanroom gowns, masks and other process protection apparels. Therefore, unlike in a dirty manufacturing environment, where users must identify hazards to human health and safety, in a cleanroom environment, it’s important to analyze hazards and risks to the process and product – the critical control points of contamination by personnel.

Hazard Analysis & Risk Assessment

Clean environment can become dirty due to human contamination:

• Even when stationary, people generate about 100,000 particles of 0.3 microns or greater. On the move, this rises to about five million.
• Every square inch of the human body has an average of 32 million bacteria on it.
• Every minute of the day, we lose about 30,000 to 40,000 dead skin cells off the surface of our skin.
• One square inch of hand surface area has an average of 10,000 microorganisms.

Part of the hazard analysis and risk assessment process involves understanding of the cleanroom environment and the allowable levels of particulates, extractables and non-volatile residues (NVR). For sterile/aseptic cleanrooms, the hazard analysis and risk assessment process should focus not only on particulate control but also on microbiological control.

Cleanrooms differ from industry to industry. Medical device manufacturers may operate at ISO Level 8 for raw material processing, ISO Level 7 for assembly and packaging and ISO Level 5 for aseptic assembly and QC testing for sterility. Pharmaceutical manufacturers may operate at ISO Level 5 for sterile filtration and aseptic filling/stoppering; ISO Level 7 for solid dose granulation, blending, compression, and coating or aseptic compounding; and ISO Level 8 for solid dose packaging and cleaning, sterile materials staging, and sterile capping, labeling and packaging.

Gloves have to be chosen as per the labels based on cleanroom classification. This helps to make sure that particulate levels, extractables and NVR levels are appropriate for the specific cleanroom class. Some manufacturers specify which gloves are appropriate for different cleanroom classes. Other glove suppliers may label their gloves as “critical” or “controlled”. There are no published standards that designate gloves as “ISO 7/Class 10,000” or “ISO 5/Class 100.” In cleanrooms, which are not very clean, it may be appropriate to use exam gloves.

Managing the Process

Many people have a stake in the process of selecting and qualifying any new product to be used in a cleanroom. Fab/production managers, contamination control manager, validation engineers, QA/QC department, cleanroom materials specialists and purchase officials should all play a crucial role. In pharma and biotech cleanrooms, local safety officers must ensure that the glove does not violate any EPA or OSHA regulations or permits. Regulatory personnel need to be involved as any changes to process may affect FDA licenses. Users will be able to provide important feedback on comfort and dexterity issues.

For aseptic cleanrooms, testing should be done on three lots of the gloves before it can be validated. Once approved, it is important to change the standards of practice for that cleanroom to reflect the new glove. Operator training is critical. Proper donning/doffing and when to change gloves must be covered when training employees on gowning procedures. Proper gowning (including gloving) should be evaluated on an ongoing basis with fresher training conducted as needed.

Performance Certification

Consistently superior performance is of utmost importance in the cleanroom environment. Shutting down a cleanroom can cost manufacturers up to $1.5 million per day. Ensure the glove you choose is not only of the highest quality, but that it also stays within a reasonable variance of that level over time. A lot of consistency should be ensured from raw materials through processing.

Acceptable Quality Level (AQL)

This refers to the probability of having defective gloves within a lot. The lower the AQL number, the lower the probability of defective gloves. While ASTM sets an AQL of 2.5, some glove suppliers exceed that standard to provide gloves with fewer pinholes and thus, a greater level of barrier protection.

Glove suppliers should provide certificates of analysis (COA) with particle counts, extractable counts and other important data for each lot of product, trend data, technical specification sheets, and certificates of irradiation (COI) if purchasing sterile gloves. Some suppliers make this information easily accessible on their web-sites after plugging in the glove’s lot number.