The EU-GMP Guideline Annex 1, Section 7.13, Part i, states that "Grade B clothing should provide protection to the product from contamination and to the personnel from the product. This clearly underlines the importance of appropriate gowning, including eye and face protection, in Grade B cleanrooms. In a Grade B environment, which is the background environment for aseptic preparation and filling, the risk of contamination is high. Therefore, the guidelines explicitly require the use of protective clothing, including eye and face protection, to ensure both product and personnel safety.
The emphasis on eye and face protection in cleanroom environments is not just about maintaining the integrity of the products being manufactured, but also about ensuring the safety of the personnel involved in the process. It's a dual-purpose strategy that aligns with both regulatory requirements and best practices for cleanroom operations. For further insights on the updated Annex 1 guidelines, pls visit our blog page here or listen to our podcast on the importance of eye & face protection in cleanroom environments.
BioClean™'s face masks, such as the DB Pouch-Style Face Masks and DB Pouch-Style Face Mask with Neck Guard, offer high bacterial, particle and viral filtration efficiency. They significantly reduce the risk of contaminants being expelled into the cleanroom environment.
BioClean™'s sterile Clearview and Vijon goggles are manufactured from lightweight ultra-soft PVC with a non-linting, latex-free headband. Their indirect ventilation system lowers the risk of contamination entering the controlled environment. BioClean™'s Clearview and Vijon models are sterilized ensuring they do not introduce any microbial contaminants into the cleanroom environment. This is particularly important in Grade A/B areas, where the presence of microorganisms must be minimized to maintain the sterility of the products being manufactured.
Indirect ventilation in BioClean™ goggles is a design feature that helps lower the risk of contamination when entering controlled environments while still maintaining clear visibility. The system works through a set of vents that are strategically placed. These vents are designed to allow air to circulate within the goggles, which helps to prevent the buildup of moisture that can cause fogging on the inside of the lens. However, the vents are not direct openings. Instead, they are designed in such a way that they do not allow straight-line passage from the interior to the exterior of the goggles, or vice versa. Importantly, this means that even though air can circulate, splashes and particulates cannot directly enter or fall out of the goggles through the vents into the cleanroom environment. This is why it's referred to as "indirect" ventilation. This design provides a balance between maintaining clear visibility (by reducing fogging), ensuring protection against potential contaminants in the environment, and preventing the release of particulates from the goggles. It's a feature that makes the BioClean™ goggles particularly suitable for use in cleanroom environments where both visibility and protection are critical.
BioClean™ Goggles packaging has a sterilization indicator sticker, which is sensitive to Ethylene Oxide. ETO renders the dots from black to green after the sterilization process. Therefore, by checking the color of these dots, users can easily confirm that the goggles have undergone ETO sterilization. If the dots have turned green, it indicates that the goggles have been appropriately sterilized. In addition to this visual indicator, BioClean™ also provides Certificates of Processing (COP) on their website which can be accessed from here.
Most users who prefer the sterile goggles choose them due to the absence of an autoclave facility and the lack of resources to manage the autoclave procedure. Some users’ work are project-based hence they only need goggles for a small number of operators whereby it makes more sense to use a disposable goggle. Certain oncology users that work with chemotherapy drugs need to treat anything that comes into contact as medical waste and hence use disposable goggles.
For tracking autoclave cycles, generally a separate log is kept, and the goggles are marked (i.e. each goggle gets its own number). Marking of the goggles is possible with an appropriate pen/marker.
Yes, reusable eye protection, like BioClean™ Clearview Autoclavable Goggles (BCAP and BCAG), can be sterilized for reuse. This also aligns with the growing emphasis on environmentally friendly practices within the industry. In terms of protection, BioClean™ Clearview Autoclavable Goggles also features an indirect ventilation system to minimize the risks of contamination from entering the controlled environments. They are made from non-linting, latex-free, and durable materials, ensuring they do not contribute to particulate contamination within the cleanroom. For comfort, BioClean™ Autoclavable Goggles are designed with adjustable headbands to ensure a secure and comfortable fit. The materials used are lightweight ensuring they can be worn comfortably over extended periods.
The BioClean™ range of autoclavable cleanroom goggles are designed to be autoclaved by hot steam at 121°C for 30 minute cycles. The goggles are very robust and can be washed prior to autoclave in water at a temperature range of between 60°C to 121°C. A mild detergent can be used as long as it is diluted in the water first – we suggest 100ml of household dish washing detergent for every 5 litres of deionized water.
A detailed instruction can be found here.
For the BioClean™ autoclavable goggles, which include models BCAP, BCAH, and BCAG, it is recommended that the housing and accessories can undergo 40 autoclave cycles*, while the anti-fog lenses are recommended for up to 25 cycles. These goggles incorporate anti-fog technology that ensures the lenses remain clear even after multiple autoclave cycles. The goggles are designed to provide an economical eye protection solution, with additional features such as an indirect ventilation system, comfortable super-soft frames, and a panoramic version to increase the field of vision. Moreover, they are equipped with durable polycarbonate lenses that are both anti-scratch and optically correct. They meet the compliance standards set by the Personal Protective Equipment (PPE) Regulation (EU) 2016/425 and are in accordance with the EN 166:2001** standard for personal eye protection.
Watch the BioClean™ goggles Anti-Fog technology in action here.
The choice of a face mask for a cleanroom is a crucial decision that can impact both the cleanliness of the environment and the comfort of the user. The key factors to consider when selecting a facemask include the filtration efficiency, breathability, and comfort of the mask. The facemask's ability to filter out bacteria and particles is vital for maintaining a controlled environment. At the same time, the breathability of the face mask, is important as it directly impacts user comfort. It's about finding the right balance between these factors to select a face mask that is both effective and comfortable for the user.
All BioClean™ face masks are at least 210mm wide (MEA/MTA) for wider face coverage to greater protect the cleanroom from particles emitted by users. The BFE/PFE/VFE help to protect the cleanroom and contents from anything emitted by the users. BioClean facemasks are low particle shedding (this is different from PFE) as tested by Helmke Drum test. The sterile versions are sterilised to SAL-6, all features and benefits are available on the product data sheet.
These are important terms when discussing the performance of facemasks. BFE, or Bacterial Filtration Efficiency, measures the mask's ability to filter out bacteria. PFE, or Particle Filtration Efficiency, measures the face mask's ability to filter out particles. Both are represented as percentages, with higher percentages indicating better filtration. Delta P, standing for Differential Pressure, measures the pressure drop across the face mask or the resistance to airflow. The lower the Delta P, the easier it is to breathe through the face mask. However, a face mask with a higher filtration efficiency typically has a higher Delta P. These measurements help us ensure that our face masks provide the right level of protection while still being comfortable to wear.
BioClean™ face masks, are designed primarily to protect the environment, including products and processes, rather than the wearer. They are used in cleanrooms and other controlled environments to reduce the risk of contamination from the wearer. While they do provide a certain level of protection to the wearer, their primary function is to protect the environment. Because of this, BioClean™ facemasks fall under a different legislative framework and are not classified as PPE. It's important to note that while they are not CE certified as PPE, BioClean™ facemasks still meet rigorous standards to ensure they are safe and effective for their intended use.
* Anti-fog performance remaining for up to 25 cycles with no degradation (under laboratory conditions)
** Not applicable for BCAH goggles