- Title
- Product-dust levels released from pharmaceutical manufacturing equipment and related health-based exposure risks
- Creator
- Van der Vyver, Pieter Smuts
- Subject
- Pharmaceutical industry -- Equipment and supplies
- Date Issued
- 2021-04
- Date
- 2021-04
- Type
- Master's theses
- Type
- text
- Identifier
- http://hdl.handle.net/10948/51936
- Identifier
- vital:43401
- Description
- The study evaluated the product-dust levels that were released from manufacturing equipment during routine manufacturing of highly potent active pharmaceutical ingredients. The study was performed at a high containment manufacturing facility for Product X. These assessments are necessary to evaluate the level of containment performance in correlation with health-based exposure limits; and from this, to develop proper control strategies for the workplace. The equipment that was evaluated in this study included barrier systems (isolators, isolation boxes), dust-proof decanting systems (split valves), soft connections covered with continuous liners, and airtight intermediate bulk containers. Methodology The amount of uncontrolled product-dust that was released during the manufacturing process was quantified by establishing an air and surface monitoring programme. This was then compared to health-based exposure levels (HBEL’s) to ensure operator safety and to implement an effective control strategy. Air monitoring involves the sampling of airborne particles through filtration of the air with a filter using a sampling pump to draw a quantifiable volume of air through the filter. The filter is then tested in a laboratory which extracts and quantifies the amount of highly potent active pharmaceutical ingredient (HPAPI) on the filter. Surface monitoring is used to assess the level of product contamination on a surface. The technique uses a suitable adsorbent material to physically adsorb surface contaminants from the surface by wiping or swabbing. Protocols were designed based on a risk assessment that took the manufacturing process, literature, and facility design into consideration. Results The HBEL level of 0.2 μg/m3 that was calculated for the manufacturing process of Product X was found to be lower than the HBEL of 1.4 μg/m3; and consequently, the level of operator exposure was well within the acceptable occupational exposure limits. All surface monitoring results passed the acceptance criteria of less than 0.032 mg/100 cm2 except for excursions that occurred during breaches in containment. Conclusion The air monitoring programme facilitated the quantification of the product-dust levels that were released into the primary manufacturing areas; which could then be verified against the HBEL of Product X. The surface monitoring programme facilitated the quantification of the product residue on non-product contact surfaces in the facility; which could then be verified against the HBEL of Product X. The objectives of the study were met for Level 2 of the high containment suite as it was possible to calculate the product-dust released from the manufacturing equipment and the product residue on external equipment surfaces and non-product contact surfaces in order to verify these levels against the relevant HBEL’s. The study enabled the assessment and impact on the current control measures, and recommendations were given to develop the control strategy.
- Description
- Thesis (MPharm) -- Faculty of Health Sciences, 2021
- Format
- computer
- Format
- online resource
- Format
- Format
- 1 online resource (xiii, 140 pages)
- Publisher
- Nelson Mandela University
- Publisher
- Faculty of Health Sciences
- Language
- English
- Rights
- rights holder
- Rights
- All Rights Reserved
- Rights
- Open Access
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Collections
NMU School of Medicinal Sciences
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | SOURCE1 | Van Der Vyver, P.pdf | 3 MB | Adobe Acrobat PDF | View Details Download |