The Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment, from the International Society of Pharmaceutical Engineering (ISPE) describes methodologies for evaluating the containment
capability of containment systems and processing equipment in the pharmaceutical and biotechnology industries under defined
conditions. (4) This updated guide, first issued in 2005, addresses a broad selection of containment technologies and processing
equipment and provides technical guidance and consistent methodologies for evaluating the particulate containment performance
(i.e., particulate emissions). The guide defines current good practices and provides information to allow organizations to
benchmark their practices and improve on them. Specifically, it provides a methodology to derive data associated with the
handling of pharmaceutical ingredients that is useful in the assessment of potential risks. The revised guide was the culmination
of a two-year process by the ISPE Containment Community of Practice to revise the original document.
Since first published, the guide has been used by containment-equipment manufacturers, pharmaceutical companies, and industrial-hygiene
consultants to perform containment verification assessments for FAT, and/or SAT of containment systems and equipment. It also
has been used to evaluate and compare equipment from different suppliers.
The revised guide identifies crucial issues that need to be addressed prior to, during, and/or at the completion of containment-performance-assessment
studies. It guides the user to perform repeatable containment verification testing to assess accurately the containment capabilities
of various containment systems and process equipment. Sections provide information and guidance on test protocols, test environment,
test material, air and surface sampling, sample analysis, sample interpretation, and reporting.
The guide specifies a methodology using a surrogate material to verify containment performance and specifies several surrogate
materials that may be used, including lactose, naproxen sodium, manitol, acetaminophen (paracetamol), insulin, riboflavin,
and sucrose. Of these, lactose and naproxen sodium are the most commonly used. The guide also provides containment equipment
test protocols to follow when performing the containment verification assessment. These seven protocols are listed in Table I.
As noted previously, prior to selection of a containment system or device, a CPT should be identified for the process, providing
the containment system supplier with a containment target for the design and construction of the unit. A CPT should also be
identified for off-the-shelf units purchased for use in standard applications such as sample weighing or dispensing. If a
CPT has not been established, containment verification testing is still applicable to ensure that unit is providing adequate
containment for the activities or processes to be performed within the unit.
Table I: Containment equipment test protocols.
The guide outlines containment verification at the supplier’s site (i.e., FAT) and when installed at the user’s site (i.e.,
SAT). The purpose for containment verification being performed at the supplier’s site is to identify and correct any deficiencies
that may impact the meeting of the CPT prior to delivery. Containment performance verification testing should only be performed
by qualified industrial hygienists, preferably under the direction of a certified industrial hygienist.
Figure 1: Area sampler positions for Protocol 5 Ventilated Enclosure, from ISPE Good Practice Guide. Table II shows the corresponding
personal, real-time and surface samples.
The seven protocols in the guide state the recommended positions for air, real-time air monitoring, and surface samples. Figure 1 from the ISPE Good Practice Guide shows the sampler positions for a ventilated enclosure. Protocol 5, Ventilated Enclosure,
specifies the sampling locations for performing the containment verification testing.
Table II: Sampling details.