Air Handling Recommendations for Pharmaceutical Laboratories handling drugs category 3 & 4. HEPA filtration of exhaust air is recommended for areas handling Category 3 substances and required for areas handling Category 4 substances. The air leaving these areas must be clean and contamination-free. A minimum of 15 air changes per...
Building Design Criteria for Pharmaceutical Laboratories
Design criteria for laboratories - General Laboratory Design: Providing a basic level of safety design for the handling of Low-Intermediate toxicity compounds.In order to ensure that a potentially hazardous environment within the Laboratory does not affect areas outside the designated laboratory, a negative differential air pressure relative to the surrounding...
Safety Design Aspects of Pharmaceutical Laboratories
Safety Design Aspects of Pharmaceutical Laboratories.The safe handling of potent compounds within a laboratory environment can be best accomplished by adopting a containment strategy which addresses two defined areas of control:The building design, which includes the air handling facilities and built in control measures such as airlocks, laboratory layout and...
Risk Analysis Checklist
Prior to working with potentially hazardous compounds or new processes within the laboratory, a risk analysis of the hazards involved should be performed. Below is a list of some consideration areas when carrying out this type of risk analysis.What data are available on the drug?What safety datasheets (SDS) are available?What...
Chemical Criteria By Drug Category
The following table shows the chemical criteria by drug category. It uses the varying properties of drugs and places them in their respective category: Low Toxicity (1), Intermediate Toxicity (2), Potent (3) or Highly Potent (4). This table is useful in determining the types of Safety and Engineering controls that need to be put in...
Low and Intermediate Toxicity Drug Compounds
Handling procedures for low and intermediate toxicity drug compounds are much less controlled than those of a potent nature, largely because their pharmacological effects, if exposed to, are less severe. Typically substances of this nature will have pharmacological effects when used in concentrations over 10mg/Kg. Low and intermediate toxicity drug...
Potent and Highly Potent Drug Compounds
Potent and Highly Potent Drug Compounds have distinct properties that mean they need to be handled in a much more controlled manner. These compounds will not be commonly handled on the open bench and require definite controlled handling procedures in order to minimise scientist exposure. Category 3: Potent Compounds A...
Categorisation of Drug Compounds
The basis of the categorisation of drug compounds is inherent to their toxicity. Drug entities are initially classified in terms of their respective toxicity and potency characteristics. Toxicity can be determined in various ways, such as through observations in pre-clinical toxicological investigations and in clinical trials. Other factors are: Mechanism...
Exposure Potential to Drug Compounds in the Laboratory
Technological advances in drug research and development provide us with increasingly effective medicines that can be taken in correspondingly lower doses, yet still achieving longer term medicinal effects. While these advancements are of obvious benefit to patients, as they will receive fewer treatments with the added advantage of longer term...