Insanitary Conditions at Compounding Facilities and Prevention Methods
In November 2020, The FDA issued an Industry Guidance document geared towards providing information in helping pharmacy compounding facilities (as well as state regulatory agencies) understand some examples of what FDA considers to be insanitary conditions that could cause a drug product to become contaminated or rendered injurious to the health of the patient.
Within this article, we will take a look at a few of those examples and discuss on some prevention methods to keep and maintain a sanitary cleanroom environment.
Insanitary Conditions Examples
Please note that the following list is a brief summary of examples of insanitary conditions that have been observed and are applicable to both sterile and non-sterile drug production and applicable to the production of sterile drugs only. These examples do not constitute a complete list provided by the FDA or potential risks that lead to insanitary condictiones.
Such examples include:
Foreign matter in the production area (e.g., rust, glass shavings, hairs, paint chips)
A facility designed or operated in a way that permits the influx of lesser quality air into a higher quality air area:
inadequate pressure differentials between areas of higher quality air and lower quality air
material flow directly between an unclassified area and a room in which sterile compounding is conducted (e.g., unclassified pass-through)
an ISO 5 area open to the surrounding area with minimal or no physical barriers separating it from non-aseptic activities (e.g., weighing of non-sterile materials, gowning, container labeling)
air returns located next to the high efficiency particulate air (HEPA) filter rather than near the floor
an open door or series of open doors between an uncontrolled area and the room in which sterile compounding is conducted
A lack of HEPA-filtered air, or inadequate HEPA filter coverage or airflow, over the critical area
Unsealed HEPA filters or loose ceiling tiles in production areas
Production areas or equipment that are difficult to clean or contain porous, particle generating, or visibly dirty (e.g., rusty) equipment or surfaces (e.g., shelving, floors, walls, doors, ceilings)
Putting on gowning apparel in a way that may cause the gowning apparel to become contaminated. This includes, for example:
gowning in non-classified areas
allowing gowning apparel (except for foot covers) to touch the floor, or other surface area that could cause apparel to be contaminated, or
putting on sterile gloves improperly (e.g., touching the outside of a glove with bare hands)
Lack of, improper, or infrequent use of a cleaning & disinfecting in the facility’s ISO 5 work areas and other classified areas.
Prevention Methods
Of course, one the biggest advantages of prevention when designing and planning a sterile compounding suite is to bring on the appropriate cleanroom vendors/consultants that have the knowledge, experience, and proven track records of designing and building these environments to navigate and meet today’s compliance requirements. Additional steps for prevention include:
Consideration on Material/Product and Personnel Workflow
Create clear patterns for bringing material in and getting finished product out while limiting the need for extra human bodies from entering the cleanroom through the use of interlocking pass-through cabinets. This method helps preserve pressure differentials and gives a clear process for the movement of materials and products.
Designing a suite that supports a unidirectional workflow of staff to avoid backtracking and crisscrossing among other staff members.
Review Buildout Components and Materials of your Cleanroom Vendor
Always check your builder on what materials will be used to build the sterile environment. Inadequate materials and components will result in failed certification, possible insanitary conditions and a major loss in investment. Ensure materials and components are easily cleanable and capable of withstanding the harsh cleaning agents. Check further on if your cleanroom is easily cleanable and steps to take HERE.
Ensure furnishings are easily cleanable and withstand rust and corrosion
Understand the difference between types of Stainless-Steel that could lead to longer life and minimizes potential for rust within the ISO rated environments.
Refresh Staff on Proper Behaviors (Gowning and Garbing) when entering the cleanroom
Old habits are hard to break. Getting all cleanroom personnel up-to-date on proper behaviors and following a tight protocol on proper gowning and garbing will go a long way toward sustainability of the cleanroom and reduce risk of insanitary conditions. Learn more HERE.
Establish a Cleaning Routine
Set up a cleaning routine within your policies and procedures and train staff often. Knowing what needs to be cleaned, how its to be cleaned and when its to be cleaned provides a clear road map to support a cleaner environment and reduces the risk for insanitary conditions or failed certifications. Read Further on Pharmacy Cleaning Guide.
Achieve Higher Standards of Compliance than the Bare Minimal
Don’t just setting for sufficient. Incorporating higher levels of best practice within your facility and operations keeps you ahead of the regulatory curve and the ability to better adapt come future changes in compliance requirements.
About ProPharma Cleanrooms
Serving health system pharmacies, 503A Compounding Pharmacies, FDA registered 503B Outsourcing Facilities and Manufacturing sites across the nation; ProPharma Cleanrooms turn-key services and cleanroom components are best-in-class. Our regulatory team carefully designs each suite to exceed standards of compliance while staying fully functional for current operations and future growth. Find out more about our full service offerings.