Michael Sassano and Antonio Guedelha: GMP Series Part 4: Laboratory Set-Up
Authored by Michael Sassano and Antonio Guedelha
The laboratory is both one of the most active and one of the most critical rooms in a GMP facility. The laboratory generates all the quality control reporting necessary to prove the quality of your final products. Laboratories have diverse diagnostic equipment pertinent to your operation, and depending on your budget, these tools can increase self-sufficiency and accuracy. Organizing the lab right is another step in your Good Manufacturing Practice (GMP) approval process that will guide your product quality and innovations.
Defining your analytical equipment needs is based on the specifications of the raw materials you will be using, excipients, solvents, intermediates and finished products to be produced in the facility. Most analytical methods in Pharmaceutical GMP are defined in the Pharmacopoeia of the region you are operating in, such as the USA, Europe, and the World Health Organization (WHO). But there are Pharmacopoeias for other countries including Russia and China In Europe, the most used Pharmacopoeia is the German version, and it is considered to be the gold standard. We are anticipating that the European Pharmacopoeia for the Cannabis monograph will be introduced in one year, and it will probably be based on or adopt the German Pharmacopeia methods. These methods specify the analytical equipment your laboratory will need, so make sure you study your specified Pharmacopeia. Further, ensure that while you’re choosing your laboratory equipment to leave room to add more equipment as your company matures.
From the beginning, you will need equipment to measure the quality of the various chemical compounds you will be creating, such as cannabinoids. Almost every GMP pharmaceutical and nutraceutical laboratory has a High-Performance Liquid Chromatography (HPLC). An HPLC is used for the identification of components, assay, and related compound testing. HPLC’s can have many add-ons like an integrated software package, autosampler, and other worthwhile upgrades if you have the budget. Another common piece of equipment is analytical scales with anti-vibration pads for weighing. These scales are used in nearly all analytical methods. Moreover, you will need a Gas Chromatography (GC) with headspace, and an auto-feeding sampler for assay, impurities quantification, and residual solvents testing.
More pertinent lab tech includes Fourier Transform InfraRed (FTIR), which is used for the identification of components; acquire a Potentiometer, which is used for titration methods. Equipment like Thin Layer Chromatography (TLC) is quite useful for the identification of components. Other tools like pH meters are helpful for determining the pH of your compounds, which is vital, as well as Ultraviolet-Visible Spectroscopy (UVS). The UVS is useful for identifying and quantifying those compounds. A Viscosimeter will measure the viscosity of your liquids and semi-solids. And finally, a Hotte is used to handle toxic and hazardous materials to protect the laboratory and the laboratory analyst(s).
If you have a large budget up front or want to add more microbiological equipment later on, consider tools such as Ultra-Performance Liquid Chromatography (UPLC). UPLCs are used in tandem with HPLCs to identify components, assay, and perform related compounds testing. Near-Infrared Spectroscopy (NIR) is a fast non-destructive method that identifies and quantifies components of raw materials and finished cannabis products. It requires long preparation times to create a database for each component that you are analyzing, and some databases exist already for sale.
Microbiological equipment is used to study and quantify small organisms such as bacteria, viruses or funguses that may exist in your cannabis compounds. Equipment like an Laminar air flow system creates a sterile environment inside the laboratory to study your samples. An Autoclave utilizes temperature and pressure to kill harmful bacteria, viruses, fungi, and spores, and it sterilizes the mediums previously prepared to test the samples.
Layout and Bench Organization
Once you have lined up your main equipment and planned for future equipment, it’s time to lay out the lab and organize your bench spaces. Sizing your laboratory has much to do with the size of your facility. If this is going to be a one-person laboratory, you’ll likely only need a few work benches for the various tasks. At minimum, you are looking at a 400 sq. ft. room. For larger operations, you may need up to 4 people and around 1,000 sq. ft. to accommodate the various tasks in safely and efficiently.
Another factor to keep in mind is the workflow benches and tasks. If the laboratory is more than 1,000 sq ft, you should have separate rooms for weighing, HPLC and GC (instrumental analysis), as well as a washing room. If the lab space is smaller, organize the areas according to these main functions to avoid cross-contaminations and usage. In any case, the microbiology laboratory must be separated from the chemical laboratory.
Position in Facility
It’s preferable to position your lab near your cleanroom areas which are producing the products; however, the lab doesn’t have to be a clean room area itself. The entrance to the laboratory must not be through any manufacturing areas. Clean room areas are expensive and being able to get the product to testing in a clean format is critical. If the laboratory isn’t in the clean room zone, you will need to pack each sample and pass it through a pass-box so the sample can be received outside of the clean room. Though this requires extra steps, it is quite a normal process. In larger facilities, a pneumatic transport system is used to send the samples to the laboratory. The samples are packed in bottles and go to laboratory for analysis before being stored in a retain samples room. The retain samples room will then keep the samples at a defined temperature and humidity.
The Laboratory Information Management System (LIMS) is software that connects lab results to the quality control reporting system (ERP). Of course, you may try manual reporting, but this isn’t advised unless you are a very small operation. Depending on the ERP selected, LIMS maybe functionality included in the ERP package. For smaller ERP solutions, you may need to acquire LIMS separately. Depending on the LIMS solutions, it can be quite expensive However, LIMS reporting is preferred by regulatory agencies reporting because the system doesn’t permit you to make changes to the analysis, so it is made up of easily traceable and validated results.
Most operations stress proper laboratory equipment, set-up, and reporting because it proves the quality of your product. Quality control is fundamental to produce consistent products safe for consumers, but also because it demonstrates repeatable and consistent performance. Adhering to the monographs of production and reporting procedures is one of the most important aspects of your manufacturing process. Don’t cut corners, and get the best equipment you can for your budget and get one step closer to becoming GMP certified.
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