Filling line sets new standards

The UK's first Macofar LVI 4 aseptic liquid filler has gone into operation at CP Pharmaceuticals in Wrexham. Supplied by Romaco UK, the machine is being used to fill vials of a new painkiller, currently in the latter stages of clinical trials, which CP is manufacturing and packaging under contract from the licence holder.

CP is currently using the LVI4 to pack the clinical trials batches, but encouraging results from the studies carried out to date indicate that the product is on track to be granted marketing authorisation in the near future, at which time CP will move to full production. New from Macofar, the LVI 4 is an automatic monobloc machine which is said to set new standards of access for cleandown and simple operator size change over. The monobloc concept also provides flexibility in the line configuration with separate filling/closure if required. Contact parts are offered in a choice of AISI 316 L stainless steel or silicon and the four volumetric filling pumps can be supplied in stainless steel or ceramic material. The dosing system comes with a choice of either ball or rotating valve and CIP or SIP systems are available as an option. The LVI can be supplied with four, six or eight filling heads and incorporates features such as individual adjustment of the pumps and the ability to carry out all adjustments from the operator's side. Output is 4000 bottles/hr, fill range 0.5cc to 500cc and vials with diameters from 16 to 85mm and heights from 35 to 200mm can be handled. CP Pharmaceuticals' production engineering manager, Jim Churchill, comments: "This is a very important product from our new client and we were charged with selecting the best filler for the task at hand. With an open brief, therefore, we were able to evaluate all major suppliers of liquid filling equipment in an objective manner. "We decided on Macofar because the machine offered high build quality, a high degree of flexibility in terms of the options we required and because Romaco offered the best all-round package in terms of supply and support. Cost was not an issue – we could have opted for more expensive machines but ultimately the LVI 4 proved to be the machine which best met our brief."

Controlled environment Although as an inhalant, the product does not need to be filled in classified cleanroom conditions, CP nevertheless wanted to create a controlled environment. The LVI 4 has therefore been supplied with a laminar flow unit and the room in which it is installed is under controlled negative air pressure. "We also wanted an option to clean the vials within the controlled atmosphere, which Macofar were happy to accommodate by incorporating an air blow/purge system at the first station," says Churchill. "Other suppliers we talked to were not prepared to be so flexible. With some the only option was to purchase an additional bottle cleaning machine which would have added considerably to the cost, complexity and size of the line." After filling, a nitrogen blanket is applied in the vial neck to protect the product and then a spray pump complete with aluminium closure is applied and rotary sealed. For batch numbering, Romaco worked with ink-jet coder supplier Domino and a small print head was installed within the controlled area. Romaco engineers completed installation of the machine and staff training in just two days. "The operators like the accessible design of the LVI4 and it is very user-friendly, particularly so because it features the standard Romaco control panel, which is familiar to us from other Romaco equipment we have on site," says Churchill. "It has run extremely well since we went into production. Because of the high value of the active ingredient, pre-production trials were carried out with a placebo. However, when we ran the first batch of live product, performance was very good, with fill patterns well within the prescribed tolerances."