Processing biohazardous materials

Agents which are hazardous at a high dose and toxic only when a substantial proportion of the filling bulk is inhaled or ingested. 

Agents which may be hazardous if the contents of a single vial are ingested or inhaled. Group III High risk 

Agents which are potentially hazardous when personnel are contaminated by a fraction of the vial contents. This category includes radiochemicals, self-replicating pathogens and untreated or untested blood or tissue samples which may be contaminated with hepatitis virus, human immune deficiency virus, etc. 

Allergenic or potentially allergenic agents not included in groups I to III. 

While it is necessary to provide adequate precautions to personnel when freeze-drying hazardous products, overcautious risk assessment can result in unnecessary or even impractical working regimes. An example where risk assessment may require modification is where live attenuated vaccines are freeze-dried on an industrial scale, when it may be operationally impossible to handle such strains with the precautions essential when processing virulent strains of that organism. 

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Irrespective of whether the freeze-drier has been fitted with filters, incinerators or other features designed to reduce internal contamination, freeze-driers used to process biohazardous materials must be capable of decontamination at the end of the cycle. As well as protecting personnel and environment from the processed agent, decontamination will prevent cross-contamination from materials previously processed within the freeze-drier. 

Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

Parts 58.41 through 58.51 cover the physical facihties of the laboratory. The inspector must determine whether or not the facilities are of adequate size and design for completed or in-process studies. The physical parameters and systems of the facilities as they are used to accommodate the various operations employed in the GLP studies are examined. Investigators also deal explicitly with the environmental control and monitoring procedures for critical areas, especially the rooms used for animal housing, the test article storage areas, and the laboratory areas in which biohazardous material is handled. The procedures and methods for cleaning equipment and areas critical to study conduct as well as the cur-... 

Prevention of the release of biohazardous materials from biotechnology processes can be achieved by applying biosafety containment principles. Consideration must be given to the containment requirements of all process steps from the initial generation of seed cultures and inocula to the handling of process effluent. The problems of treating off gases and liquid effluent are discussed elsewhere (chapter 12). This chapter will consider the application of containment principles to prevent release of hazardous material from unit processes at laboratory and pilot plant scales. 

Other. If the possibility of the release of biohazardous material from a biotechnology process operation has to be accepted, then it may be appropriate to consider the use of personal physical protection of the worker in the form of positive (or negative) pressure respiratory protection... 

The architectural services integrate the design of the facility so that it can support the corresponding process the flows of people, materials, products and waste, product separation, sterile processing, sanitary design, biohazard containment, special utilities, and solvent recovery, handling and storage. 

Biological waste can be taken off-site by a contractor for treatment at their facilities. However, most facilities treat biological waste on site. Materials potentially contaminated with infectious materials are placed in biohazard bags in pans and these pans are treated with high temperature and steam in an autoclave. There are established protocols and procedures for doing this. It is important that no volatile organic solvent be included in this process, since this could lead to exposures or fires. 

In these initial studies, the purpose has not been to compare the biohazards due to different materials or processes. The results show that bio-... 

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