This is defined by the compounding category (Category 1, 2 and 3) and the garb associated with it. For Category 1 and 2 compounding, cleanroom frocks (snaps in front) should be snug around the neck without causing discomfort and enclose as much exposed skin and street clothes as possible. For hazardous drug sterile compounding, also category 1 or 2, Contec® CritiGear™ Chemo HD Gowns fasten in the back and must also be secured in a snug fashion. The idea behind this is to limit the amount of skin shedding that can occur during compounding (frocks), and the amount of exposed skin that can be impacted by hazardous drug exposure (gowns).

Category 3 sterile compounding requires all sterile garb which must be obtained from a validated sterile cleanroom garb supplier of either disposable or washable garb. This type of compounding also requires different head and face covers. The garb described above is not suitable for compounding Category 3 CSPs.

Firstly, beyond-use dates only refer to CSPs so don’t use that wording for disinfectants. If you're asking about the "use by" date of disinfectants - please refer to the webinar that Contec hosted in 2022 In section 7.1.2 the revised Chapter states, "Once opened, sterile cleaning and disinfecting agents and supplies (e.g., closed containers of sterile wipers) and sterile 70% IPA may be reused for a time period specified as by the manufacturer and/or described in the facility written SOPs."

Section 8.1 of USP <797> states “Before any item is introduced into the clean side of anteroom(s), placed into pass-through chamber(s), or brought into the SCA, providing that packaging integrity will not be compromised, it must be wiped with a sporicidal disinfectant, EPA-registered disinfectant, or sterile 70% IPA using low-lint wipers by personnel wearing gloves. If an EPA-registered disinfectant or sporicidal disinfectant is used, the agent must be allowed to dwell for the minimum contact time specified by the manufacturer. If sterile 70% IPA is used, it must be allowed to dry. The wiping procedure should not compromise the packaging integrity or render the product label unreadable.”

All products must be removed from cardboard packaging in the anteroom outside the cleanroom. Before any item is introduced into the clean side of anteroom(s), placed into pass-through(s), or brought inside the perimeter of an SCA it must be wiped with PeridoxRTU®, PreEmpt ® RTU, TB1-3300™ or Sterile 70% IPA using low-lint wipers by personnel wearing gloves.

Sterile items will be packaged with an inner and an outer bag. After sanitizing the outer-bag one can open and remove the inner bag while inside the Buffer area. Before any item is introduced, Contec recommends to wipe it with sterile 70% IPA using low-lint wipers and allowed to dry before use.

Yes, we invite you to work with our Contec Healthcare Expert to improve your critical cleaning processes and implement best practices. We will assist you to select the Contec Healthcare wipes, mops and solutions that best fit your application. More importantly, we will help you design procedures that meet or exceed USP standards. To arrange a trial, or to learn more about Contec Healthcare and our products please contact a Contec expert.

Yes, please check the official EPA List N for an updated list of disinfectants that are effective against COVID-19. Please note some items may be under a master registration EPA number listing. If you have questions, please contact your local Contec Healthcare representative for support. Please note some items may be under a master registration EPA number listing. If you have questions, please call your local Contec Healthcare representative for support. For all other COVID-19 information please visit our Contec COVID-19 resource page.

Spores can survive in regular 70% isopropyl alcohol (IPA). Sterile alcohol is used to prevent the chance of contamination from spores that might be present in lower grades of isopropyl alcohol. Contec® Sterile IPA is produced by filtering a solution of USP grade 70% isopropyl alcohol and 30% purified water through a 0.2 micron filter to prevent spores from entering the bottle. Then, the product is terminally sterilized to a 10-6 Sterility Assurance Level (SAL). This means that there is less than a one in a million probability that there is 1 cfu (colony forming unit) in the bottle. This process is verified by validation documentation. Contec Healthcare uses this same alcohol blend in the production of our sterile presaturated wipes. These products are terminally sterilized and are also validated to a 10-6 SAL.

Sterile alcohol manufacturers do not follow the same manufacturing protocol. Some companies do not manufacture in a clean environment or keep a documented record of the steps taken to validate the alcohol to a sterile level. Contec® Sterile 70% Isopropanol is made in the United States and validated sterile according to USP guidelines.

If you have a specific organism that is not on the product label which your customer's facility wants to address, please contact your Contec Healthcare expert. Contec Healthcare will work with you to determine the best path forward for your product efficacy requirements.

We offer Contec Healthcare TB1-3300™ Disinfectant in sterile and nonsterile liquid and wipes. Contact your local Contec Healthcare Expert for information and samples.

Our wipes and mops for the Compounding Pharmacy market, by definition, are “lint-free”, “non-shedding”, and “low-lint”. These terms are expected to be defined in a pending Recommended Practice of the Institute of Environmental Sciences Technology (IEST) as follows:

Non-shedding, low-lint, or lint-free wiper: A wiper exhibiting few, if any, fibers or other contamination, visible without magnification, which is separate from, or easily removed from the wiper material in a dry condition. Note: Materials containing natural fibers (e.g. any cotton, or cellulose content of 65% or more) are generally not considered to meet this definition. (Institute of Environmental Sciences and Technology Recommended Practice IEST-CC-RP-004.4 (pending)).

We have detailed documents that help with best practices minimizing exposure limits, current occupational exposure limits by influencing entities, and then what to do with measurements in regards to PPE.  Contact your Contec Healthcare Expert for this documentation, and taking advantage of our In-service to review current facility practices for application techniques.

Chemistries can impact people differently, as everyone has their own sensitivities to products around them. The best thing to do is review best practices for application of PeridoxRTU®, occupational exposure limits and thresholds, and ultimately personal protective equipment that can be voluntarily offered if below the exposure limits. Nuisance masks can make a difference, but again, only if correctly reviewed. Charcoal containing nuisance masks with OV/AG can make a big difference in an end users experience. Contec Healthcare has documents that can help with best practice, currently exposure limits published by OSHA and other influencing entities and options to measure, and what to do with the measurements obtained. Contact your Contec Healthcare Expert for this supporting information.

Ready-to-use disinfectant products are preferred for pharmacies. They ensure repeatability of process and eliminate the need for creating operating procedures for mixing, including water purity verification. Ready-to-use products also ensure that the correct amount of active ingredient is present, and often a longer shelf life vs. diluted solutions.

Contec Healthcare products, including PeridoxRTU®, are available in the US through one of our authorized healthcare dealers. To purchase PeridoxRTU in Canada, please email Contec Customer Service.

Yes. PeridoxRTU® Sporicidal Disinfectant & Cleaner, when used according to Contec Healthcare procedure, effectively removes chemotherapy residue from surfaces contaminated by hazardous drugs. It is ideal for cleaning, decontaminating and disinfecting surfaces pharmacy cleanrooms. Contact your Contec Healthcare expert to learn more.

PREempt cannot be offered sterile due to its chemical makeup. Contec recommends both TB1 3300™ Sterile and PeridoxRTU® sterile for your needs. Contact your Contec Healthcare Expert for a sample.

Yes, designed for maximum mechanical removal of contaminants and even distribution of a disinfectant on walls and floors during a terminal clean, the Klean Max™ mop head is the perfect product in this environment. It is used once per room then discarded.

Yes. USP <797>, Section 4.4 on Water Sources requires that a sporicidal disinfectant be applied to the surfaces of the sink at least monthly. The sink basin and faucets are the most likely source of microbial contamination in a sink that could spread to other areas of the cleanroom suite. Although USP <797> does not specify that the sink drain is part of this requirement, sink drains can harbor microbial contamination in the form of a biofilm. The drain should also be disinfected periodically or if the results of environmental monitoring indicate elevated contamination near the sink. Some sink-drain piping materials, especially cast iron, copper, or chrome-plated brass, can be corroded by chemicals poured into the drain. To avoid this issue, the drain should be thoroughly rinsed with running water for approximately 1 minute after the disinfectant has achieved its sporicidal wet contact time (3 minutes) with the drain piping.

It is not uncommon to see cotton mops or relaundered microfiber products in operating rooms. According to strict USP guidelines, these products are not allowed into the pharmacy. Mopping systems and buckets should be dedicated to the pharmacy cleanroom and should not be used in other areas. Contec Healthcare offers many non-shedding mops for ISO Class 7 & 8 rooms.

Yes, according to section 7.1.1 of the revised Chapter, sterile disinfectants MUST be used in the PEC.

According to the revised USP Chapter <797> (2023) - Section 7.1.2 states "cleaning and disinfecting supplies used in the PEC must be sterile with the exception of tool handles and holders, which must be cleaned and disinfected prior to use in a PEC.

Yes. PeridoxRTU® Sporicidal Disinfectant & Cleaner, when used according to Contec Healthcare procedure, effectively removes hazardous drug residue from surfaces contaminated by hazardous drugs. It is ideal for cleaning, decontaminating and disinfecting surfaces in pharmacy cleanrooms. Contact your Contec Healthcare expert to learn more.

Cleaning refers to the removal of visible debris, dirt, and other contaminants from surfaces, while disinfecting refers to the use of chemicals to kill germs and pathogens. Both cleaning and disinfecting are necessary in hazardous drug handling areas to prevent the spread of hazardous drug contamination. 

No, USP <800> does not require specific disinfectants. However, disinfectants used in hazardous drug handling areas should be effective against a broad range of pathogens and should be compatible with the surfaces being disinfected. 

The recommended contact time for disinfectants varies depending on the specific product. Always follow the manufacturer's instructions for proper use. 

Since these drugs are hazardous, primary and secondary engineering controls are set up to facilitate containment of HDs. Containment Primary Engineering Controls (C-PEC) such as Biological Safety Cabinets (BSCs), Compounding Aseptic Containment Isoloator (CACIs), or Containment Ventilated Enclosures (CVEs) are vented to the outside of the facility above the roof, and they function at a pressure that is negative to the adjacent space. The room in which the C-PEC is located is called the secondary engineering control which is also engineered to be negative pressure to the room to which it is adjacent. Engineering controls cannot by themselves ensure HD containment.