High containment control
Applied Containment Engineering has just completed an installation for Pfizer
Applied Containment Engineering has just completed an installation for Pfizer
Applied Containment Engineering, a leading supplier of specialist barrier/isolation systems based in Dewsbury in the UK, recently undertook a multi-isolator project for a US company. The installation involved product sampling and offloading from a filter dryer, sub-division and sampling of active and excipient material, dispensing, reactor charging and material transfer to and from kegs. The individual processes and transfers between them, including clean-down operations, required an OEL of less than 300ng/m³.
A series of purpose-designed isolators with transfer technology formed the basis of the containment solution. All systems had to be compatible but specific to each individual operation and process.
A purpose-designed isolator system for product offloading, sampling and heel removal from a Comber filter dryer was built. The design of the isolator and the control interface also enabled the operations to take place at the isolator by incorporating duplicate controls into the isolator local control panel. Safety interlocks were provided, with signals feeding back to the Comber control system.
The double chamber design of the isolator with rapid transfer port (RTP) access to the lower chamber allowed for contained charging of drums. As the isolator internal environment was inert using nitrogen, monitored by oxygen sensors, the safety interlocks allowed for purging of nitrogen from the unloading chamber only, enabling removal/replacement of sealed drums.
The sub-division was combined with the dispensary operations contained within a triple chamber isolator, consisting of the loading, dispensing and unloading chamber. The loading chamber was furnished with a pneumatic drum carriage to allow the drum to be over-bagged and sealed to the rear of the dispensing chamber. In effect, this extended the dispensing chamber into the loading chamber without compromising either chamber condition.
The main chamber allowed for product to be weighed out and charged into a keg through an RTP, separating the main chamber from the unloading chamber.
Material can be introduced to the dispensing chamber via a dedicated RTP, ergonomically positioned to allow the bagged material to be connected and charged. A weigh platform was also provided internally, with the display and alphanumeric key panel housed externally, thereby minimising congestion and reducing the size of the internal chamber.
As the internal environments are inert, oxygen monitoring was provided to ensure the internal atmosphere was purged with air before opening. In addition, the system displaces nitrogen with a minimum 18% oxygen once the stop button has been pressed.
The requirement for reactor charging – as with most reactors – was for access and intervention, therefore anything proposed had to be either mobile or easily removable. By utilising the RTP bag technology a smaller single chamber reactor charging isolator was designed. This contained a product charging RTP in the roof of the isolator, a sample transfer RTP on the side, a reactor sampling spigot in the isolator, and a chute to connect to the reactor.
As this type of unit needed to be removable, a mobile station was designed to house the HVAC, controls and instrumentation. The design was such that the isolator could be positioned on the mobile station and wheeled into location. The isolator can then be lifted from its mobile station and connected to the reactor.
Site trials of the equipment supplied were carried out using sodium bicarbonate for technician training, while surrogate testing was done using Naproxen sodium, with a containment level well below 100ng/m3.
Paul Richards, senior research engineer at Pfizer global research and development, said: 'The isolation systems were designed for our specific applications through innovative engineering, a flexible approach to design, and customer focus.'
NovAseptic makes testing times foolproof
Sanitary equipment supplier NovAseptic has developed a novel presterilised, disposable, totally enclosed sampling system for use where an imprecise or false result can lead to quarantine, necessitating a repeat analysis, new samples or products that are unacceptable.
The company says equipment used in the sampling process is often seen as the largest single source of contamination. The very nature of the traditional through valve" methodology, which requires multiple manual connections, also lends itself to operator error and contamination.
With the enclosed NovaSeptum sampling system, the requirement to carry out CIP/SIP procedures during preparation of the traditional sampling device is eliminated, the company says, while the integrity of the sample is guaranteed from point of use to analysis, thus ensuring its sterility, avoiding false positives and facilitating validation.
Moreover, as the NovaSeptum system is easy to handle, set up and dispose of, it is claimed to cut sampling time dramatically, providing quicker throughput to the laboratory and rapid return of the results.
The disposable units, which are presterilised by radiation and guaranteed to be pyrogen-free, also ensure the provision of a representative sample as each one is taken without flush directly from the batch.
The simplicity and adaptability of the system make it suitable for a wide range of applications, including sterility and pyrogenic testing, bacterial counting, chemical and pH analysis and fermentation.
The NovaSeptum can also be used for contamination-free transference of fluids into vessels and pipes, making it ideal for applications such as bioreactor starter inoculations and pH regulation, NovAseptic says.
The units are assembled in Class M6.5 cleanrooms from FDA and USP Class VI approved materials and are available in sizes from 20ml up to 1,000ml.
T +44 1954 231144
F + 44 1954 232443
jamesmillard@novaseptic.co.uk