Keeping
an eye on the footprint
Delivering high performance to pharmaceutical contract packers and fillers

Economists seem to look at outsourcing as a magic formula. Large corporations in particular concentrate on their core areas of expertise and contract out ancillary processes to external specialists. Contract packers and fillers
have been sought-after partners for quite a long time, and they have to supply systems that are able to
cope with any eventuality.


In the pharmaceutical industry, where safety is of prime importance, it is hard to imagine that anyone would contemplate ignoring standards simply to reduce costs. This makes confidence in a contract packer even more important, and it applies to both the personnel and the equipment. When a leading contract packer decided to acquire a syringe filling system, the decision had be well thought through and have a very sound basis.
The decision by the contract packer to purchase two
Inova lines was not difficult because the company already had experience with the supplier. Two Inova lines, which are used primarily to fill and process BD Hypak SCF syringes,
have been in operation since the beginning of the year.
The system is also capable of filling
glass or plastic pre-sterilized syringes up to 20 ml in size made by other manufacturers. When processing 0.5 ml syringes, the system reaches its peak performance of 22,500 syringes per hour. In the 1 to 3 milliliter range, the system fills and seals 18,500 syringes per hour. The entire filling and sealing system is located in a small-format, customer-supplied sterile room. To achieve maximum hygiene protection, the entire machine system is placed in a laminar flow. At the beginning of the process, an Inova SHR robot automatically transports the sealed tubs to a decontamination unit.
The robot automatically removes the Tyvek foil and the insert which protects the syringes against particle contamination in the nest. Next, the syringes are moved to the filling and sealing system, where rotary dosing pumps fill syringes at ten stations simultaneously. The stoppers are inserted immediately after that. Finally, an automatic transport system removes the finished syringes.

Minimizing system
space requirements
It is no secret that cleanrooms, in this case class 100, are expensive. This makes it all the more important to minimize the space used by the machines. Inova has further reduced the space requirements of its H3-10e filling and sealing system and the SHR robot, which were already considered to be compact. A new design, which is being used for the first time by the contract packer, features a special method of integrating the machine in the cleanroom. To save additional space, the system is docked directly at the cleanroom wall.
The rear of the machine’s protective enclosure is positioned directly at the wall. This means that operation of and access to the entire machine is only possible from one side.
In addition to size reduction and the resulting improvement in accessibility, the design of the machine was also changed to enhance ease of operation and cleaning. The machine line is resistant to aggressive cleaning agents. To accomplish this, the company has minimized gap dimensions, designed in seals made of special materials and made use of stainless steels surfaces. The system is robust and has been designed for many years of use.
Safety is the primary
consideration
To safeguard proper process flows and hygiene to the maximum extent possible, the machine’s protective enclosure features RABS design similar to isolator technology. It includes safety protection devices such as light barriers, glove access and special door handles.
Dosing precision in the filling machine is ultimately a safety issue which affects the pharmacist, the doctor who has to administer the injection and the patient. Over or under dosage of active ingredients can have serious health consequences. Thus the contract packer bears a heavy responsibility to the pharmaceutical company. In the 0.1–1 milliliter filling range, the dosage must be accurate to within 1 percent. If the filling volume is greater than one milliliter, accuracy must be
within 60.5 percent.
The system has been in operation since the start of the year, and it is operated by a single person in the cleanroom. A complete format change can be completed in less than 30 minutes. Because of its high availability, the machine is run on multiple shifts.