STAXS® ASSORTMENT
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DOTCH®
DOTCH®
DOTCH® is the STAXS®'s product range. The DOTCH® products meet the highest standards needed in contamination control in cleanrooms. The DOTCH® motto is Scientific Credibility. The product information available depending on product type is plentiful: material traceability, bioburden, CFU's count, particles count, absorbency, shelf life, sterility validation and so much more.
Disposable garments
Humans are the greatest contamination source in a cleanroom environment. Cleanroom apparel is needed to prevent the contamination of the environment from viable and non-viable particles, such as bacteria, yeast, dead skin cells and hair. Innovative solutions for cleanroom garments are a must. The lastest Annex 1 update states that "The clothing and its quality should be appropriate for the process and the working area. It should be worn in such a way as to protect the product from contamination".
Disposable garments
Humans are the greatest contamination source in a cleanroom environment. Cleanroom apparel is needed to prevent the contamination of the environment from viable and non-viable particles, such as bacteria, yeast, dead skin cells and hair. Innovative solutions for cleanroom garments are a must. The lastest Annex 1 update states that "The clothing and its quality should be appropriate for the process and the working area. It should be worn in such a way as to protect the product from contamination".
Spectacle & Goggles
The new revision of the GMP Annex 1 doesn't leave any doubt on the use of goggles and spectacles in cleanrooms. Wearing sterile eye gear and protection in A-B cleanroom areas is a must. Goggles protect the environment from the sheddings of skin particles or eye droplets. The sterilisation, packaging and validation of the goggles is of the utmost importance and has been researched to provide the best solutions. The product needs to offer the necessary protection and also be comfortable for long time wear.
Spectacle & Goggles
The new revision of the GMP Annex 1 doesn't leave any doubt on the use of goggles and spectacles in cleanrooms. Wearing sterile eye gear and protection in A-B cleanroom areas is a must. Goggles protect the environment from the sheddings of skin particles or eye droplets. The sterilisation, packaging and validation of the goggles is of the utmost importance and has been researched to provide the best solutions. The product needs to offer the necessary protection and also be comfortable for long time wear.
Gloves
Cleanroom gloves are designed to protect either products from contamination or the wearer from exposure to chemicals. Once the main reason for wearing the gloves is established, there are many other glove characteristics to be considered – the required tactility, dexterity, antistatic materials, glove length and more. Our gloves' range covers all possible needs and uses.
Gloves
Cleanroom gloves are designed to protect either products from contamination or the wearer from exposure to chemicals. Once the main reason for wearing the gloves is established, there are many other glove characteristics to be considered – the required tactility, dexterity, antistatic materials, glove length and more. Our gloves' range covers all possible needs and uses.
Detergent & Biocides
According the new Annex 1 draft, cleaning and disinfection are considered two seperate processes and are both particularly important and complementary. Disinfectants and detergents should be monitored for microbial contamination. The dilutions are kept in previously cleaned containers and stored for defined periods. Efficacy of disinfectants should also be demonstrated. The selection of disinfectants should not be thought of as a one-off decision, but be part of the on-going quality reviews.
Detergent & Biocides
According the new Annex 1 draft, cleaning and disinfection are considered two seperate processes and are both particularly important and complementary. Disinfectants and detergents should be monitored for microbial contamination. The dilutions are kept in previously cleaned containers and stored for defined periods. Efficacy of disinfectants should also be demonstrated. The selection of disinfectants should not be thought of as a one-off decision, but be part of the on-going quality reviews.
Mops
The choice of the mopping system is crucial to the successful cleaning and disinfection regime for a cleanroom environment. Mops are very convenient and ensure contamination is being physically removed from the cleanroom. Care must be taken that many disinfectants can be adversely affected by the wipe substrate. Key factors for consideration which type of mop to use include ease of use, coverage, cleanliness (particles and fibres), compatibility with chosen disinfectants and detergents, availability of sterile product if required, packaging and cost. Also, the type and roughness of flooring needs to be taken into account, as does the type and the amount of soil/residues that need to be removed.
Mops
The choice of the mopping system is crucial to the successful cleaning and disinfection regime for a cleanroom environment. Mops are very convenient and ensure contamination is being physically removed from the cleanroom. Care must be taken that many disinfectants can be adversely affected by the wipe substrate. Key factors for consideration which type of mop to use include ease of use, coverage, cleanliness (particles and fibres), compatibility with chosen disinfectants and detergents, availability of sterile product if required, packaging and cost. Also, the type and roughness of flooring needs to be taken into account, as does the type and the amount of soil/residues that need to be removed.
Syringes
Syringes
The DOTCH® syringes are developed under strict scientific procedures and to fulfill all the regulations for medical devices. These are for general purpose injection/aspiration of fluids and for general purpose injection/aspiration of fluids below the surface of the skin.
Wipes
How to select the best wipe for the job? The first step is to determine the objective: the removal of any soiling, particulates or liquid without causing any abrasion to the surface or the application of a disinfectant and subsequent removal of microbial contamination. The structure, composition and cleanliness of the wipe material is very important. It is also important that the wipe does not contribute to the bioburden or generate additional particles in controlled environments.
Wipes
How to select the best wipe for the job? The first step is to determine the objective: the removal of any soiling, particulates or liquid without causing any abrasion to the surface or the application of a disinfectant and subsequent removal of microbial contamination. The structure, composition and cleanliness of the wipe material is very important. It is also important that the wipe does not contribute to the bioburden or generate additional particles in controlled environments.
Face & beard protection
Face & beard protection
Operators introduce a significant amount of particles as well as microorganisms into a clean area. Protective equipments keep such particles and microorganisms contained and prevent them from contaminating the final preparation as well as assist in maintaining better environmental control.
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Shoes
Annex 1 requires dedicated shoes per cleanroom classification, either sanitizable or autoclavable. They must be lightweight, easy to put on/off, have an anti-slip sole for safe manoeuvering on wet surfaces and offer protection against falling objects. But above all, they must be comfortable to wear.
Ear protection
Ear protection
Protecting your staff's hearing is crucial. Harmfull noise is now recognised as an irreversible health hazard. Since April 2019, all CE marked PPE products placed on the market must be compliant with the PPE Regulation. Severall principles such as hearing protection changed, before categorised as ‘harmful noise’ (risk) is now moving from Category II to Category III. Next to your staff's wellbeing, selecting the right PPE is critical to compliance on two main elements: Is it adequate ? Is it suitable?
Cleaning systems & tools
Cleaning systems & tools
Efficient cleaning requires cleaning accessories that are easy to use, easy to clean, resistant to corrosives and for use in grade A/B easy to sterilise. Most common materials used are made of RVS or PET.
Spill mats
Spill mats
The spill protection mats offer a high protection against spillage and reduce the contamination risk in cleanrooms or isolators. They need to have the following properties: suitable for use in up to ISO 5 areas - as it is very low linting, high liquid holding capacity, porous top layer, bonded reservoir layer and impermeable back layer.
Markers, Pens & Tape
Markers, Pens & Tape
The available writing material in cleanrooms needs to fulfill the applicable regulations. The DOTCH® markers and pens range satisfies the requirement for control of writing equipment in cleanrooms.
Packaging
Packaging
As a final step in a GMP oriented cleanroom, the packaging products need to offer an easy and effective protection against contamination. The cleanroom chain stays safe and clean until the last production step. The key to making a successful choice in packaging films is first looking at the challenges your product gives you. Requirements need to be developed for strength, particle cleanliness, ionic cleanliness, moisture and gas barrier, and budget.
Swabs
Swabs
Cleanroom Swabs provide precision surface cleaning, surface sampling validation, TOC validation, and the application of lubricants or other liquids within cleanrooms and other controlled environments. Every swab has been designed with different lengths, head sizes, and materials to meet very specific customer needs.
Cosmetics
Cosmetics
Hand sanitisation is of importance. Personnel carry many types of microorganisms on their hands and such microorganisms can be readily transferred from person to person or from person to equipment or critical surfaces. Such microorganisms (including Staphylococcus, Micrococcus and Propionibacterium) are either present on the skin not multiplying (transient flora) or are multiplying microorganisms released from the skin (residential flora). Performing appropriate hand hygiene is crucial to avoid contamination. The wearing of gloves doesn't absolve from the need for hand hygiene.