Facilities and equipment

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All aseptic manipulation must take place in EU grade A work zones. These can be provided by horizontal or vertical laminar air flow cabinets or positive-pressure isolators.


Facilities and equipment

 

All aseptic manipulation must take place in EU grade A work zones. These can be provided by horizontal or vertical laminar air flow cabinets or positive-pressure isolators. For hazardous drugs, such as cytotoxics and radiopharma-ceuticals, the use of a negative-pressure isolator is recommended to provide protection not only to the product, but also the operator(s). The grade A workstation must be located in a controlled background environment, usually of EU grade B, although some isolators may be located in an EU grade C or D background. Figure 6.4 shows horizontal laminar flow workstations used for IV additive work.


 

Automated filling equipment may be placed in the critical work zone providing it is fully validated. Figure 6.5 shows an automated system.

 


 

The Rules and Guidance for Good Pharmaceutical Manufacture and Distribution and Quality Assurance of Aseptic Preparation Services should be consulted for exact standards and requirements of facilities and equipment. Specialist guidance on isolator technology is also available.

 

In addition to the critical aseptic handling areas, areas must be desig-nated for setting up ingredients, producing batch documents and labels, and checking and packing the finished product. Handling radiopharmaceuticals requires additional equipment to protect the operator from ionising radia-tion and to monitor exposure levels. Also, tandem isolator systems are necessary to include the technetium (Tc99) generator in the controlled work area (Figure 6.6). Operators are required to wear body badges and finger badges in order to quantify the amount of exposure they have received. They must also follow systems of work which control exposure by either mini-mising the time spent directly exposed to the source of radiation or by maximising the distance from it. Such practices include working behind lead glass shields and the use of syringe and vial shields and lead housing for generators. These shields must also be accommodated within the isolator or class 2 cabinet workstation. Tongs are used to increase the distance between the operator and the doses. Dose monitors are also used to check for spil-lages and contamination and are subsequently used to ensure such incidents are cleared up appropriately. There are specific elements of operator training which must be covered besides the routine pharmacy training. There are also local rules which must be read which cover the safe systems of working with radiation. The introduction of the robotic arm for manipulation of radio-pharmaceuticals should further increase operator safety.



 

Process

 

Wherever possible, all aseptic processes should be based on closed systems so that the product or the product fluid path has only minimal exposure to the environment. Product segregation is essential to prevent gross contamin-ation and separate clean rooms and workstations should be used for cytotoxic drugs and radiopharmaceuticals. Operator technique is critical and all opera-tors, processes and equipment must be fully validated.

 

The manipulation of cytotoxic drugs requires additional protective cloth-ing and emergency procedures for spillage management. These are detailed in non-official UK guidelines. To avoid aerosol formation, venting nee-dles and filters or purpose-designed fluid transfer devices must be used when adding and withdrawing liquids to and from vials. In the case of aseptic products, environmental monitoring and the use of routine media-fill simula-tions are more meaningful than sterility tests, which are designed to be used with terminally sterilised medicines. Support from an experienced QA depart-ment is essential not only for the validation of all aseptic processes but also for formulation and shelf-life issues with aseptic preparations. The addi-tional risks associated with unintentional intrathecal administration of cer-tain cytotoxic agents have led to additional guidance on the presentation, process and release of these products. With a few exceptions, all vinca alkal-oid doses must now be presented as large-volume infusions (50 ml) to prevent the lethal intrathecal administration of these drugs.

 

The processes involved in the preparation of radiopharmaceuticals require consideration of additional issues, including the prescribing and scheduling doses, which are often complex. Most doctors who request scans are not authorised to prescribe radioactive pharmaceuticals. Requests must therefore be authorised by the local Administration of Radioactive Substances Advisory Committee licence holder before they can be scheduled into the nuclear medicine clinic. To maximise the scanning capacity of a nuclear medicine department, doses need to be ready at the beginning of the working day. An on-site radiopharmacy can help facilitate this and enable the service to be more flexible when responding to urgent requests. In contrast to routine CIVAS work, radiopharmacy staff start dose preparation first thing in the morning and early starts of 7 a.m. are not unusual. Reconstitution of kits requires the addition of a radionuclide and saline to a ligand contained in a sterile vial. The resulting solution may need to be incubated for a set period to ensure the radionuclide has attached to the ligand. Simple QC analysis can be performed to confirm the radiochem-ical purity of the radiopharmaceutical. Poor-quality radiopharmaceuticals may expose patients to radiation unnecessarily and their treatment may be delayed while the investigation is repeated.

 

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