Rapid transfer port technology High Purity day Vught, NL 04 June 2014 1
Objective Presentation of rapid transfer port technology AGENDA What is an RTP History of RTP s How do they work and where are they used, or can be used. What alternatives are there to RTP s The new RTP, the Sterile Liquid Transfer Port Discussion and wrap up 2
What is a rapid transfer port? A rapid transfer port viewed from inside an isolator 3
What is a rapid tranfer port? RAPID TRANSFER PORTS A means of rapidly transferring items into and out of a controlled environment without compromising the environment and without the need for a intermediate decontamination process A mechanical system which exists in a number of different diameters Simple to validate 4
RTP - main components classic design Enclosure wall Beta seal Alpha flange Beta flange Beta door Alpha door Alpha seal 5
RTP - main features AN RTP SYSTEM MUST HAVE: Known leak tightness performance Reliable mechanical interlocks Reliable and validated containment performance Good ergonomics for ease of use Fully interchangeable parts Application compatible materials 6
Optima TS - main components Security mechanism Alpha flange Alpha door Beta flange Alpha seal Beta seal Beta door 7
Objective History Originally designed during the development of nuclear power in France in the early 70s to replace a bagging out process as more secure and reliable way of removing contaminated items from nuclear glove boxes. 1 st patent applied for in 1973. Late 70s - beginning of the use of RTPs in the Pharma and chemical industries. 1990 FDA approval of the 1 st beta bag application. Last major patent for the original design falls into the public domain 2009. Optima TS and STUC patent applied for 2008. Optima TS and STUC patent approved 2009. Optima TS and STUC patent extension for Europe approved 2010. First prototype completed end 2010. Public launch of 1 st major innovation since the original design November 2011. 8
Technology presentation RTP principle of operation 9
RTP How does it work the ring of concern 10
Alternatives to RTPs Spray and pray Mouse holes or what is better described as dynamic outlets. Autoclave or dry heat tunnel interface Transfer chambers using chemical low temperature biodecontamination such a s VHP Simple door (does not maintain the integrity of the controlled environment) Split butterfly valves such as the Charge point valve The UK Yellow guide includes a description of the various forms of transfer devices 11
RTP applications fluid transfers RTP autoclavable container with fluid connections for filling line RTP container can be steam sterilized with the product vessel 12
RTP applications fluid transfers RTP viewed from the inside RTP container can be steam sterilized with the product vessel 13
RTP in the Pharma industry MSD Mirabelle France Introduction/re moval of environmental monitoring consumables Introduction of stoppers using a rapid transfer port In another part of this facility RTPs are used to introduce plastic product containers using beta bags. Annual usage is between 6000 and 8000 bags 14
Technology presentation RTP principle of operation Applications Introduction of syringe pistons using RTP rapid transfer port 15
RTPs on filling line isolators Introduction of environmental monitoring consumables using RTP Isolators for Aseptic Production Transfer and Loading of 4 Freeze Dryers Taking product samples using RTP 16
RTPs on SIP containers for the stopper transfer Beta flange with steam in place cover Transfer vessels ready for loading and SIP 17
RTP applications Introduction of stoppers using RTP rapid transfer port 18
RTP in research connecting two Bio-safety cabinets 19
Optima TS system validation Non viable particulate One transfer using the Optima TS rapid transfer port is guaranteed to be 40 times less of a contamination risk than a HEPA filter on an Grade A enclosure running with 20 air changes per hour (tested using 0.3µm particles) in a grade D background environment. Viable particulate Equivalent to 1 year usage of a rapid transfer port placed between a sterile enclosure and an external (2m 3 second enclosure) contaminated with an air borne suspension of log 8 spores of ATCC 12980 did not contaminate the sterile environment. Environmental monitoring in the sterile enclosure carried out using active air sampler, settle plates and swabs of the Optima TS surfaces which are exposed in the sterile environment when the alpha door is opened. 20
STUC TS TS 190 beta part 21
STUC TS TS 190 beta bag example 22
Any questions? Jon Nottingham, Director Cape Europe Ltd., 80 Waddington street Norwich Norfolk NR4 3JL UK Tel 0044 (0)7909598533 Fax 0044(0)1264393103 E-mail: cape-europe@ntlworld.com Web site Cape-Europe.com 23