Russell Finex vibro shifter helps a pharmaceutical manufacturer maintain the highest level of containment.

Sieving equipment is an integral part of most pharmaceutical processes and the primary role to ensure ingredients and finished products are quality assured during production and before use or despatch. When processing active pharmaceutical ingredients, the occupational exposure limit (OEL) has a significant part to play in the design of a process to ensure operators are not at risk to exposure. Therefore, when Cipla Ltd built their OEL compliant plant at their Goa factory in 2005, having a sieving machine that would ensure product quality and integrity without compromising the safety of their operators was essential.

In recent years, the pharmaceutical industry has seen a growing demand for products that require active pharmaceutical ingredients and with the introduction of highly potent active pharmaceutical ingredients, the concern for operator’s safety due to the adverse effects related to the handling of dangerous compounds is becoming more prevalent. Although a range of personal protective equipment (PPE) is widely available, this can only reduce exposure levels rather than eliminate them. Therefore, having certified plant equipment that can help reduce OEL levels must be considered an advantage not only to improve the working environment of operators but also to reduce costs associated with sophisticated PPE and dust containment systems.

Cipla’s new OEL compliant plant was built for the manufacture of a new highly potent drug and as with nearly all processes handling pharmaceutical powders, to ensure specification and quality were upheld, a number of sieving operations were required. Firstly, on incoming pharmaceutical raw materials to remove any oversized contamination and secondly, after granulation to remove undersized particulates.

Due to the vibrating action of a sieve, dust can be generated very easily and therefore the need for a high containment sieve was required. The OEL level 5 sieving machine offered by vibro shifter manufacturer Russell Finex was used. Known as the Russell Compact Airlock Sieve, it utilises a pneumatic clamping system, which, combined with its patented Twist Lock Inflate (TLI) technology, provides a uniform dust-tight seal.

The unit is clamped together with a revolutionary airlock system. The pneumatic lock gives an even and high clamping force across all sealing faces and therefore guards against powder leakage more effectively than traditional band clamps or over-centre toggle clamps. Through independent tests this veritable clamping system has been certified to an OEL value less than 1µg/m3 (OEL level 5).

The new Airlock screener utilises the Russell Compact technology to increase screening efficiency allowing even sticky products to be sieved without blinding. Also, due to its new clamping system, it is extremely easy to dismantle when compared to conventional clamping methods.

Assembly and disassembly of the screening machine is achieved in seconds. The component parts are placed into the base and located by twisting and locking the lid without the need for tools. The airclamp is then inflated to secure and seal the unit during operation. The sieving unit is suitable for either continuous or batch operations and also lends itself to applications where a number of different products are being processed due to the simplicity and speed with which it can be disassembled and cleaned.

The plant has been in operation for over 3 years and Cipla have been looking at ways to improve the process further. Although the cGMP design of the vibrating sifter is based on clean lines making sanitation easier, reducing the exposure of operators to products during clean down of the sieve can be achieved by retrofitting the Russell WIP system. This spray ball system allows an even spray on the product contact parts to wet the components prior to dismantling the sieve improving handling of the components during clean down. Russell sieve thus offers high-quality design, finish and performance.