EVIO Labs Florida received their ISO 17025:2005 accreditation in February of 2018. Last week, EVIO Labs Florida announced via a press release that they completed their ISO 17025:2017 accreditation and received a certification from AOAC International. The accreditation helped them to further expand their testing scope to shelf life and stability testing, the ability to detect harmful bacteria and calculate degradation in samples.
The certification that they received from AOAC helps verify their ability to conduct accurate and fair 3rd party testing, meeting Florida’s requirements for the market. Back when the laboratory first started in 2017, there were no requirements for lab testing cannabis products under Florida’s regulations.
Upon expanding to their Gainesville location in November last year and getting accredited to ISO 17025:2017 last week, EVIO Labs Florida expects the new location to be compliant and operational by April 2019, in preparation for the state’s new regulations. “Our team has worked diligently to maintain our stance as the Gold Standard in Cannabis Testing,” says Chris Martinez, co-founder and president of EVIO Lab Florida. “The ability to obtain the recent ISO 17025:2017 and AOAC certification is a testament to our dedication in maintaining public safety and product integrity in an ever-growing industry.”
Martinez is also presenting during the 2ndAnnual Cannabis Labs Virtual Conference on April 2, where he will discuss how EVIO Labs Florida began as a laboratory and how they were able to expand to a second location and grow their market presence in Florida. Click here to register for his talk.
The outside environment can vary widely depending on where your facility is located. However, the internal environment around any activity can have an effect on that activity and any personnel performing the activity, whether that’s storage, manufacturing, testing, office work, etc. These effects can, in turn, affect the product of such activities. Environmental control strategies aim to ensure that the environment supports efforts to keep product quality high in a manner that is economical and sensible, regardless of the outside weather conditions.
For this article, let us define the “environment” as characteristics related to the room air in which an activity is performed, setting aside construction and procedural conditions that may also affect the activity. Also, let us leave the issue of managing toxins or potent compounds for another time (as well as lighting, noise, vibration, air flow, differential pressures, etc). The intent here is to focus on the basics: temperature, humidity and a little bit on particulate counts.
Temperature and humidity are key because a non-suitable environment can result in the following problems:
Increased operator error
Difficulty in managing products (e.g. powders, capsules, etc)
Degradation of raw materials
Microbial and mold growth
USP <659> “Packaging and Storage Requirements” identifies room temperature as 20-25°C (68-77 °F) and is often used as a guideline for operations. If gowning is required, the temperature may be reduced to improve operator comfort. This is a good guide for human working areas. For areas that require other specific temperatures (e.g. refrigerated storage for raw materials), the temperature of the area should be set to those requirements.
Humidity can affect activities at the high end by allowing mold growth and at the low end by increasing static. Some products (or packaging materials) are hydroscopic, and will take on water from a humid environment. Working with particular products (e.g. powders) can also drive the requirement for better humidity control, since some powders become difficult to manage in either high or low humidity environments. For human operations without other constraints, a typical range for desirable humidity is in the range of 20 to 70% RH in manufacturing areas, allowing for occasional excursions above. As in the case of temperature, other requirements may dictate a different range.
In a typical work environment, it is often sufficient to control the temperature, while allowing the relative humidity to vary. If the humidity does not exceed the limits for the activity, then this approach is preferred, because controlling humidity adds a level of complexity (and cost) to the air handling. If humidity control is required, it can be managed by adding moisture via various humidification systems, or cooling/reheating air to remove moisture. When very low humidity is required, special equipment such as a desiccant system may be required. It should be noted that although you can save money by not implementing humidity control at the beginning, retrofitting your system for humidity control at a later time can be expensive and require a shutdown of the facility.
Good engineering practice can help prevent issues that may be caused by activities performed in inappropriately controlled environments. The following steps can help manage the process:
Plan your operations throughout your facility, taking into account the requirements for the temperature and humidity in each area and know what activities are most sensitive to the environment. Plans can change, so plan for contingencies whenever possible.
Write down your requirements in a User Requirement Specification (URS) to a level of detail that is sufficient for you to test against once the system is built. This should include specific temperature and RH ranges. You may have additional requirements. Don’t forget to include requirements for instrumentation that will allow you to monitor the temperature and RH of critical areas. This instrumentation should be calibrated.
Solicit and select proposals for work based on the URS that you have generated. The contractor will understand the weather in the area and can ensure that the system can meet your requirements. A good contractor can also further assist with other topics that are not within the scope of this article (particulates, differential pressures, managing heating or humidity generating equipment effects, etc).
Once work is completed, verify correct operation using the calibrated instrumentation provided, and make sure you add periodic calibration of critical equipment, as well as maintenance of your mechanical system(s), to your calibration and maintenance schedules, to keep everything running smoothly.
The main point is if you plan your facility and know your requirements, then you can avoid significant problems down the road as your company grows and activity in various areas increases. Chances are that a typical facility may not meet your particular requirements, and finding that out after you are operational can take away from your vacation time and peace of mind. Consider the environment, its good business!
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