Written By: Matthew Greer, Technical Writer, PSC Biotech®
Introduction
Starting up a new laboratory can be a daunting task. What regulations need to be followed? What kinds of products are you handling? What kinds of tests will you do?
Once you know this, you need to consider the best layout for your laboratory. You need to identify the test and laboratory safety environment.
Let’s discuss a few of the factors you want to consider in planning your new laboratory. First, having the right team is essential, and if you need help, PSC Biotech® has the resources that you need.
Avoid the Common Mistakes
Before breaking ground, you need to consider how will you laboratory be utilized? What products will be tested in this lab? What are the methods associated with these products?
Are there any safety equipment or special requirements necessary for each one? Fire extinguishers, eye wash stations? Fume hood, Biosafety Hoods, Glove boxes? Gowning, Degowning? Chemical and Biohazard Waste storage? Autoclave or Dry Heat Oven? Flammable, Acid, Base, and Oxidizer storage? Personnel low, Sample flow, Sample Storage? Design your laboratory on paper first.
You must understand the tests the laboratory will be asked to perform, including chemistry and microbiology tests for raw materials and in-process, final product, stability, and validation samples.
Next you need to select the appropriate test equipment to perform the tests. How accurate, how precise, how sensitive, etc. does the equipment have to be? Oh yes, and remember that everything needs to calibrated.
Which type of utilities will be needed? Electricity, Gas, Air, Nitrogen, Vacuum, Water?
Do you need Purified Water, Water for Injection, Distilled Water? Make sure the correct water systems are installed for your planned testing.
Do you need to control the laboratory temperature and relative humidity? How about vibration or light? Do you need an ISO classified environment, such as an ISO 5 room or hood for aseptic operations?
Don’t forget the Paperwork
What about your quality management system? Policies, procedures, forms, records, etc., are essential. If it isn’t documented, it didn’t happen. If you need a Quality management System that is plug and go, consider ACE Essentials™, our cloud-based fully cGMP compliant system that comes with all the necessary Standard Operating Procedures (SOPs), quality event management, training management, and even more features to have your new laboratory in compliance from its very start.
These are just a few of the things that you need to consider when starting up a new laboratory. Overwhelming? PSC is here to help.
About PSC Biotech®
PSC Biotech® is a life science and biotechnology consulting company founded in 1996. We can provide you a complete turnkey solution or with the specialized, qualified consultants with expertise in the areas you need, such as laboratory operations, writing documents, validating equipment, analytical methods, validation, and gap assessments.
Let’s get your new laboratory up and running! Contact us today!
