Use of the laminar flow hood in your compounding pharmacy is a necessity to protect your products and the patients that use them. We offer tips on its use including how we can help you procure all the right cleaning products and PPE apparel needed to property use the hood.
The enclosed workstation creates a contamination-free work environment by forcing air through filters to capture all the particles entering the cabinet. But without proper aseptic technique, the cabinet alone cannot protect your compounded pharmaceuticals. The hoods are most useful for the aseptic handling of specific media.
How a Laminar Flow Hood Works
The hood pulls a streamline air flow through a pre-filter and one or more HEPA filters removing bacteria, fungi, dust, and other particulates to create a particulate-free environment.
The filtered air exits the filtration system across the work surface toward the compounding pharmacist to create the smooth, non-turbulent flow of air or laminar flow.
The laminar flow hood is enclosed on all but the front sides enabling constant positive air pressure to prevent contamination from intruding into the cabinet.
Key Procedures for Effectively Running a Laminar Flow Hood
- Before running the laminar flow hood, ensure nothing that can be damaged by UV rays is present inside the work area.
- Sterilize the glass shield and any product components or tools to be left inside the cabinet.
- Close the glass shield before switching on the UV light to begin sterilization; leave on for 15 minutes to completely sterilze the surface of the working bench.
- Switch off the UV light waiting 10 minutes before turning the airflow on. Notes: The UV light and airflow should not be used at the same time. And no work should be conducted when the UV light is on.
- Then turn on the airflow and wait 5 minutes before beginning work inside the hood.
- To start work, open the glass shield and turn on the fluorescent light for illumination of the work surface. Also, if your standard operating procedures call for it, use sterilants such as hydrogen peroxide and 70% IPA with lint-free wipers to wipe down the inside of the cabinet from dirtiest to cleanest areas.
- Follow aseptic technique carefully and diligently per your SOP to maintain sterility of the airflow at and around key points of your compounding.
- At completion of the work, sterilize the glass shield and any components left inside the cabinet.
- Turn off airflow and florescent light and close the glass shield. Then turn on the UV light for sterilization.
Cleaning Your Laminar Flow Hood
Use pre-saturated lint-free cleanroom wipes or wipes saturated with a cleaning agent or sterilant specified in your SOP.
Note that wipes and cleaner should be placed inside the cabinet then as each wipe or the cleaner is used, they are kept inside the cabinet without exiting the work area during the cleaning procedure. Once all surfaces are clean, remove the used wipes, cleaner, and any tools and dispose of or sterilize them.
Note: Note: the video does NOT show proper garbing, but does show proper cleaning technique.
Compounding Inside a Laminar Flow Hood
- Place all supplies at least 6 inches inside the outer edge of the working surface.
- Remove dust covering from supplies before placing them on the working surface.
in the hood. - Avoid placing objects (including your hands) between the airflow and other objects or placing objects too close together. Place smaller objects closer to the HEPA filter and larger supplies farther away from the filter.
- Swab any surface with 70% IPA or a betadine solution and a sterile lint-free wipe prior to puncturing avoiding depositing excess sterilizing solution that could enter the product.
- Minimize hand movement remaining mindful of hand position and the direction of airflow over injection ports or objects being manipulated so that the airflow is never diverted away from the most critical points such as punctures and syringe plungers.
- To assemble needles and syringes, peel back the protective coverings and attach the needle and syringe, twisting to lock in place being careful to not touch any surface that will come in contact with the sterile solution.
- Keep hands, products, and tools at least 6 inches inside the outer edge of the hood.
- Do not remove hands from the hood until the compounding procedure is completed including final inspection of the formulation.
- Place all syringes and needles in puncture-proof containers and dispose of them according to SOP.
Sterile Cleanroom Staff Hygiene
Staff’s personal cleansing and hygiene play an important role in reducing the microbial burden. Cosmetics shed particles and should not be used when entering a cleanroom. Also, staff with irritated or infected skin evidenced by rashes, abrasions, cuts, sunburn, or weeping sores or active respiratory infections shed particles at higher rates and should not be permitted to enter the cleanroom. Jewelry and visible piercings should also be prohibited. Cleanroom staff should not use artificial nails or extenders and should keep their natural nails trimmed. Hands must be cleansed carefully.
Hand Hygiene
Hand hygiene is the most effective method of preventing the transmission of pathogens that cause infection among people including, and especially, in health-care settings. Proper hand-washing is an essential component of good sterile compounding practices.
Waterless, alcohol-based hand sanitizers that exhibit persistent activity (that is, effectiveness for six hours) and comply with guidelines and/or criteria from the USP, the FDA, and the Centers for Disease Control and Prevention (CDC), are among the most effective products that ensure an appropriate level of hand hygiene during compounding.
In studies of antimicrobial-resistant organisms, alcohol-based products reduce the number of multi-drug resistant pathogens recovered from the hands of health-care workers more effectively than hand washing with soap and water.
Most alcohol-based hand antiseptics contain one or a combination of isopropanol, ethanol, or N-propanol. Alcohols are effective anti-microbials because they have the ability to denature proteins and to disrupt cell membranes of bacteria, fungi, and viral capsids causing cell death. Alcohol solutions that contain between 60% and 95% alcohol are most effective as higher concentrations are less effective because water is required to denature proteins.
A summary procedure of proper hand washing procedure as specified in Appendix II of the USP-NF Chapter <797> is below:
- Removes all jewelry, watches, etc., up to elbow
- Starts water and adjusts to appropriate temperature
- Avoids unnecessary splashing during process
- Uses sufficient antimicrobial cleanser and scrubs thoroughly for at least 30 seconds
- Scrubs hands starting with fingernails first
- Cleans all four surfaces of each finger
- Cleans all surfaces of hands, wrists, and arms up to the elbows, using a circular motion
- Does not touch sink, faucet, or other objects that may contaminate hands during the process
- Rinses off all soap residue
- Rinses hands holding them upright and allowing water to drip down to elbow
- Does not turn off water until hands are completely dry
- Turns off water with a clean, dry, lint-free paper towel
- Does not touch faucet or sink while turning off water
Garbing for Working in a Laminar Flow Hood
Sterile pharmacy compounding inside a laminar flow hood requires the same attention to detail that any cleanroom procedure requires.
Garbing consists of proper hand-washing designed to reduce the amount of potential contamination followed by donning the appropriate cleanroom apparel as specified in your SOP which may include any or all of aprons, sleeves, gloves, hoods, shoe covers, coveralls, head coverings, beard coverings, lab coats, smocks, bunny suits, bouffant caps, and facemasks.
Both handwashing and use of cleanroom clothing donned in a specific way are designed to reduce the particle shedding count from cleanroom staff.
The appropriate order of garbing is vital covering from the “dirtiest” to the “cleanest” areas of a person’s outside clothing or skin.
Appropriate Order of Garbing
Prior to entering buffer area or segregated compounding area:
- Remove all personal outer garments
- Remove cosmetics
- Remove jewelry from hands, wrists, or any other visible body parts
- Don cleanroom apparel in the following order:
- Sterile shoe covers or dedicated shoes placing the covered foot on the clean side of the line of demarcation
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- Head covers and, if needed, facial hair covers
- Sterile face masks
- Aseptic goggles or eye shields
- Carefully wash hands up to elbowsl
- Then don a non-shedding sterile gown
Our staff can help you select the right cleanroom apparel, wipes, and cleaning supplies to properly operate your laminar work bench. We offer a lowest price guarantee. Call us today to talk to an experienced cleanroom professional and for free samples of all our cleanroom supplies.