People as a Contamination Source in Pharmaceutical Clean Rooms-Source Strengths and Calculated Concentrations of Airborne Contaminants.

Results are presented from studies performed in a test chamber on clean room garments used, laundered, and sterilized (autoclaved 20 min at 121°C), 50, 60, and 70 times, and garments used, laundered, and sterilized with a prolonged autoclave cycle 50 times. The source strength is described as the mean value of the number per second of airborne particles and aerobic colony-forming units (CFUs), respectively, emitted from one person dressed in the system to be evaluated. Results from body-box tests have been used to calculate theoretical expected concentrations of airborne aerobic CFUs and particles (≥0.

Comparison of three distinct clean air suits to decrease the bacterial load in the operating room: an observational study.

Background: Lowering air-borne bacteria counts in the operating room is essential in prevention of surgical site infections in orthopaedic joint replacement surgery. This is mainly achieved by decreasing bacteria counts through dilution, with appropriate ventilation and by limiting the bacteria carrying skin particles, predominantly shed by the personnel. The aim of this study was to investigate if a single use polypropylene clothing system or a reusable polyester clothing system could offer similar air quality in the operating room as a mobile laminar airflow device-assisted reusable cotton/polyester clothing system.

Comparison of three distinct surgical clothing systems for protection from air-borne bacteria: A prospective observational study.

Background: To prevent surgical site infection it is desirable to keep bacterial counts low in the operating room air during orthopaedic surgery, especially prosthetic surgery. As the air-borne bacteria are mainly derived from the skin flora of the personnel present in the operating room a reduction could be achieved by using a clothing system for staff made from a material fulfilling the requirements in the standard EN 13795. The aim of this study was to compare the protective capacity between three clothing systems made of different materials - one mixed cotton/polyester and two polyesters - which all had passed the tests according to EN 13795.

Some observations on airborne particles in the critical areas of a blow-fill-seal machine.

Regulatory authorities set requirements on factors such as maximum allowed airborne particle concentrations in critical areas and the surrounded environment. An important issue when producing sterile drugs by aseptic processing with blow-fill-seal technology is to achieve Class 100 (ISO Class 5) in the critical area. To meet these requirements high efficiency particulate air (HEPA)-filtered airflow is used to dilute and remove airborne particles.

Some observations on airborne particles in blow-fill-seal filling rooms.

Pharmaceutical products produced by blow-fill-seal (BFS) technology are manufactured in clean rooms of different cleanliness classes. Regulatory authorities set requirements on factors such as the maximum allowed airborne particle concentration in filling rooms with BFS machines. To meet the requirements of the authorities, the supply air is HEPA-filtered.

Loading and unloading of freeze-dryers: airborne contamination risks for aseptically manufactured sterile drug products.

In pharmaceutical manufacturing, freeze-drying processes can be adversely affected by temperature differences relative to the surrounding air. Loading and unloading of freeze-dryers are performed either without or with temperature differences between the cleanroom and the chamber of the freeze-dryer. This operation can cause a flow of room air through the opening, creating a contamination risk, especially when manual handling of material is performed in this area.

Current practice in the operation and validation of aseptic blow-fill-seal processes.

In order to illustrate current practice in aseptic blow-fill-seal (BFS) technology, a worldwide survey was performed by the BFS International Operators Association. The results are summarized and compared to the media fill data from the Product Quality and Research Institute (PQRI) survey reported in 2003. The survey highlights the differences and shows the robustness of the BFS technology.

Modern cleanroom clothing systems: people as a contamination source.

Today, clothing and clothing systems for cleanrooms are mainly tested with regard to material properties such as particle generation, particle filtration, and resistance to wear. The dispersal chamber or "body-box" has been used for studying the protective efficacy of clothing systems in use, for example by Hoborn in 1981 (1) and Whyte and Bailey in 1985. A modified dispersal chamber has recently been installed at KTH.