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OEB risk classification and corresponding protective measures
Date: 2025-09-19Read: 5
Occupational Exposure Limit (OEL) refers to the maximum concentration of suspended particles in the air of a certain pollutant, at which almost all workers are able toRepeated exposure to this pollutant day after day will not cause adverse reactions. Usually expressed as a time weighted average of eight hours per day (PC-TWA), similar to PEL (permissible exposure limit) or TLV (threshold limit value) regulatory limits. The National Health Commission of the People's Republic of China, abbreviated as NHC, is responsible for formulating TWA standards in our country.
The pharmaceutical industry typically comes into contact with over 85000 types of drugs or intermediates during drug production, which have varying degrees of exposure hazards, but only about 1000 have publicly credible Occupational Exposure Limits (OEL). Therefore, the National Institute for Occupational Safety and Health (NIOSH) in the United States proposed the concept of Occupational Exposure Classification (OEB).
The full name of OEB is Occupational Exposure Band, which literally means the range of exposure levels caused by occupational specialization. It is used to identify the exposure hazard level of drugs with undisclosed Occupational Exposure Limits (OEL). It is equivalent to the sealing level that needs to be paid attention to when storing and transporting pharmaceutical raw materials with toxic diffusion ability. The higher the sealing level, the greater the diffusion hazard of such materials, and the more attention should be paid to the implementation of safety measures for sealed storage.
Therefore, in the process of drug contact, we need to: 1) determine the OEL value of the treated drug; 2) Refer to the recommendations in the OEB classification to determine the protection level; 3) According to OEB recommendations, use the correct facilities.
OEB is an internal management measure in the pharmaceutical industry, and there is no unified standard for its classification. Generally, the following classification principles should be followed:
Table 1 Classification of Occupational Exposure Levels (OEB)
Figure 1 Classification Table of Occupational Exposure Levels (OEB)
For example, in a 50 square meter, 5-meter-high room, achieving these concentrations only requires 1/10 of the sample in the small bottle below.
Preventing the leakage of highly active substances during processing and transportation is the primary key control point. The commonly used engineering control measures are generally:
1) The OEB 4-5 level product line should adopt fully enclosed equipment and facilities. When it comes to occupational contact, isolation devices, glove box sealed operations, alpha beta valves, bag in bag out and other control measures should be used;
2) The OEB Level 3 product line should use sealed equipment and facilities as much as possible when it comes to occupational exposure, and select appropriate locations for drug dust exposureLaminar flow hoodIndependent operating compartments with local ventilation devices (LEVs), fume hoods, and other control measures;
3) The OEB 1-2 level product line requires the installation of local induced draft facilities, such as effective local ventilation at exposed points.
On November 12, 2021, in order to guide and standardize the co production of drugs, the NMPA Verification Center organized research, drafted, and released the "Guidelines for Quality Management of Co production of Drugs (Draft for Comments)". In Chapter 4, it is proposed that in order to avoid cross contamination of highly toxic and highly active products during co production, new products introduced into existing production lines and equipment can be classified according to occupational exposure limits (OEL). The classification standards are shown in Table 1, and different control measures should be taken for the production of drugs with different toxicity and activity.
When conducting risk assessment on products intended for co production, analysis should be conducted based on the specific problems of the co production products. Risk identification and analysis can refer to but are not limited to the following aspects: the characteristics of the co production varieties, the processes of the co production varieties, the intended use of the co production varieties, and the sharing of the plant and facilities of the co production varieties.
Solution:
Anruis balance weighing cover, horizontal airflow inside the cabinet, top enclosed design, avoids the risk of toxic dust falling onto the table during weighing or filter replacement, complies with OEB5, and is more conducive to the stability of high-precision balance readings. Professional waste recycling equipment can be selected to collect waste through recycling bags to avoid secondary pollution outside the cabinet. If you want higher accuracy, you can choose "Bag in Bag out",The bag in and out is a sealed box with a unique HEPA lower sealing design, which can ensure that the inside of the box is not polluted and reduce the spread of hazard sources. In addition, the sealed bag in and out of the bag is a special safety bag of TPU (thermoplastic polyurethane elastomer, which is thick, tough, wear-resistant, and anti-aging), with a tightening device and a recycling pouch for waste bags at the mouth. The biggest feature of the bag in and out of the box is that the installation and replacement of the filter are all carried out under the protection of a dedicated TPU bag, and the filter unit does not come into contact with the outside air, thus ensuring the safety of personnel and the environment.
(Airflow direction diagram)
Case Study
Bag in bag out balance weighing cover
