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Three Tests for Disinfectants for Cleanroom Validation

by Gerbig in General Cleanroom. Comments Off on Three Tests for Disinfectants for Cleanroom Validation

You need to control fungal contamination in your cleanroom, and you need to test the disinfectants for validation. Here are three to consider.

Controlling fungal contamination in your cleanroom requires cleaning and disinfection procedures. Your disinfectant application is a critical step that needs validation. Since many agents that are effective against vegetative fungi aren’t effective against fungal spores, it’s necessary to conduct a series of tests to demonstrate your agent’s efficacy. Here are three testing methods to consider.

Suspension tests. These are especially valuable for finding how much time is needed to reduce organisms to an acceptable level. However, they don’t reveal any variations in efficacy that happen when disinfectants are applied to different surface types. The test procedure is to suspend the microorganism in an appropriate dilution of the test disinfectant. At designated time intervals, samples are removed for viable counts. … Read More »

Methods for Testing Container Closure Integrity : Cleanroom Products – Part 2

by Gerbig in General Cleanroom. Comments Off on Methods for Testing Container Closure Integrity : Cleanroom Products – Part 2

Container closure integrity is a must for drug manufacturers. Here are the last 2 of 5 common methods to test this integrity

As mentioned in part 1, container closure integrity (CCI) is paramount for the entirety of the shelf life of any drug product. There are numerous ways to test CCI. In part 1, we discussed dye ingress testing, vacuum decay, and headspace analysis. Here we will wrap up with the final two most popular methods: helium leak and high voltage leak detection.

Helium Leak. While the previous methods discussed are not extremely sensitive, this test is the most accurate, giving the most reproducible results. Helium is one of the safest gases to use for such a test, and the vials or syringes can be filled manually or arrive with helium in them.  A mass spectrometer that only detects helium ions picks … Read More »

Methods for Testing Container Closure Integrity: Cleanroom Products – Part 1

by Gerbig in General Cleanroom. Comments Off on Methods for Testing Container Closure Integrity: Cleanroom Products – Part 1

There are a number of alternative methods to test container closer integrity for drug products. Start comparing these methods here.

Container closure integrity (CCI) of a drug product must be preserved throughout its entire shelf life. There are a number of ways to conduct a CCI test, each with its pros and cons.  Here is a rundown of the most familiar methods.

Dye Ingress Testing. This is probably one of the most popular tests used. Some of the benefits are that being a visual test, the drug can be in its final configuration (syringe or vial.) It also only requires an observation of the dye to see whether the container has been compromised. This is a basic and efficient means of testing; however, it should only be used as a gross analysis of cracks and misalignment. There are much more sensitive tests … Read More »

3 Ways to Sterilize Cleanroom Apparel – Part 2

by Gerbig in General Cleanroom. Comments Off on 3 Ways to Sterilize Cleanroom Apparel – Part 2

Part two explores gamma irradiation as a sterilizing technique for aseptic cleanroom garments.

Sterile garments are a regular part of any aseptic cleanroom. Most companies require that all components in this kind of controlled environment, including garments, be terminally sterilized to 10-6SAL. There are a few ways of accomplishing this.

In part 1, we discussed the first two of three methods of sterilizing these garments: steam autoclaving and EtO. While both methods have their upsides, neither is considered the most advantageous given the culture and needs of today’s cleanroom. This brings us to the third, most preferred method of garment sterilization: ionizing radiation.

Ionizing Radiation

This includes two forms, though gamma irradiation is the only one being successfully used in cleanrooms. The electromagnetic radiation of gamma rays has great penetrating power, like an x-ray, but with a shorter wavelength. Sterilization with these rays occurs … Read More »

3 Ways to Sterilize Cleanroom Apparel – Part 1

by Gerbig in General Cleanroom. Comments Off on 3 Ways to Sterilize Cleanroom Apparel – Part 1

Sterility is a major part of every cleanroom, be it the equipment, the tools, the product, or the structure. In aseptic cleanrooms, the garments must also be sterile. Most companies require all components in an aseptic cleanroom – including garments – to be terminally sterilized to 10-6SAL.  There are three methods of achieving this: autoclaving, ethylene oxide (EtO), and ionizing radiation (gamma or electron beam.)

Let’s look at the first two.

Steam Autoclaving

As the name suggests, sterility is attained in this method using steam and pressure. The garment is wrapped in a vapor-permeable bag and placed under a high temperature. The steam carries heat to every surface of the garment. So long as the object in the autoclave isn’t heat, pressure, or moisture-sensitive, this method is reasonably efficient and convenient. However, it typically shrinks garments up to two sizes. Aside from the … Read More »