Marcus Schütte (Product Management) Sebastian Prühl (R&D) Competitive Analysis Sterisart Universal Pump Symbio

Transcription

1 Marcus Schütte (Product Management) Sebastian Prühl (R&D) Competitive Analysis Sterisart Universal Pump Symbio

2 Short Overview (1) Feature Sterisart Universal Pump Symbio Merck Millipore (Isolator Version) Content of the delivery (Box) Pump, Drainage container, Holder for bottles, Cover for Sterisart, Support rod, Tubing, Display with integrated Barcode Scanner for 16420; without Pump, Drainage container, Holder for bottles, Cover for Millipore units, Support rod, Tubing, Display, External Box for power supply Manual yes yes External Box for Power Supply Not needed Yes, mandatory

3 Short Overview (2) Feature Sterisart Universal Pump Symbio Merck Millipore Pump versions 2, one with display (16420) and one without (16419) Display adjustable in height and angle yes 3, one for installation in Isolators (IS), one for usage under laminar flow and 1 for? No, and only limited in angle Removeable Display with Plug yes No, fixed installed Quality of Display (front) Glas Glas Quality of the pump (316L) & (316) Barcode Scanner Yes, integrated in No Touch Screen Yes No Stainless steel and Chrome?

4 Short Overview (3) Feature Sterisart Universal Pump Symbio Merck Millipore Flexibility to use Sartorius consumables and Millipore consumables Yes, cover / adapter for using Millipores consumables available No, Merck does not offer a solution to operate Sartorius consumables Additional Box for Software needed no Slits for Ventilation no no List Price (Euro) yes

5 Competitive Analysis Sterisart Universal Pump - Merck Millipore Symbio Pump (Isolator Version)

6 Holder for bottles USB Stick Ethernet cable Cover for Millipore disposables Drainage Container Cable for power supply Silicone tubing Support rod

7 Holder for support rod Display Box for external power supply; cable, to be connected on the bottom

8 Bottom adapter for connection of power plug Page 65

9 Quick connector Cable not easily removable in case of damage Page 65

10 Adapter for fixation of the support rod Threat with gasket for fixation of the bottle holder on the support rod

11 Threat with gasket fixed on the support rod Scratches

12 Quality issues Support rod after hand tight screwing and unscrewing of the bottle holder Scratches Scratches Page 66

13 Adapter of the drainage container Insert for drainage container at the pump

14 Boot time: 18 sec. Opening of rotor: 8 sec Closing of rotor: 6 sec Inserting the tubing and closing the pump head - > costs without handling time 14 sec Consequence: Extended time consuming sterility testing process

15 Boot time: 7 sec. Opening of rotor: 0 sec Closing of rotor: 0 sec Inserting the tubing and closing the pump head - > costs without handling time 0 sec Consequence: More tests can be done in the same time span

16 Foil on the pump made of plastic Consequence: High risk of detaching the low quality foil after several cleaning steps with cleaning agents

17 Can not be removed Rotor can be unscrewed Consequence: Only a few parts can be removed. Not easy to clean and not in full compliance with GMP guidelines

18 Lid of the rotor with screws (bottom view) Consequence: Not easy to clean with cleaning agents. No complete disinfection possible and not in full compliance with GMP guidelines

19 Drainage container with the sterility testing consumables positioned in the rear area Consequence: Not easy to handle the sterility test consumables due to the inconvenient position. Lost of space in the front of the drainage container. Not possible to position materials needed for the test there.

20 Sterisart consumable do not fit in Merck Millipores drainage container by purpose! Consequence: Merck Millipore is actively preventing a second supplier by the design of the drainage container (no risk mitigation possible) and of course preventing price competition by that strategy

21 If the tubing is not correctly being inserted, an error message is coming up on the display and the pump stops Consequence: Easy to insert the tubing in a wrong position. Unexperienced operators may call the service of Merck Millipore -> loss of time

22 Wrong insertion of the tubing into the pump Correct insertion Correct insertion shown in detail

23 Sterisart Universal Pump Equinox Pump from Merck Millipore New Symbio Pump Isolator Version Merck Millipore

24 Equinox Pump from Merck Millipore Sterisart Universal Pump New Symbio Pump Isolator Version Merck Millipore

25 Steritest Symbio Isolator version: Upper part in the Isolator almost 9 cm height Consequence: Very high operational height which is inconvenient for most operators performing test for sterility in an Isolator and/or clean bench

26 height of disposables in Symbio Pump: Almost 22 cm Consequence: Very high operational height which is inconvenient for most operators performing test for sterility in an Isolator and/or clean bench

27 Sterisart Universal Pump: Upper part in the Isolator approx. 4 cm height Consequence: Very low operational height which is most beneficial for the operator performing test for sterility in an Isolator and/or clean bench

28 height of disposables in Sterisart Universal Pump: Only 12 cm Consequence: Very low operational height which is most beneficial for the operator performing test for sterility in an Isolator and/or clean bench

29 height of disposables in Sterisart Universal Pump: Only 12 cm Consequence: Very low operational height which is most beneficial for the operator performing test for sterility in an Isolator and/or clean bench

30 Quality of Materials Glass Stainless steel High Quality drainage container made of PP-HT Cover for inserting the sterility test consumables made of stainless steel Container for draining can be autoclaved at correct conditions (121 C, 20 min with 30 min incubation at RT) minimum 50 times Consequence: Long lifetime of the pump due to high quality materials; Sterilization: can be gassed with vapourized H2O2, UV-light desinfection, Autoclaving of drainage container, cover for drainage container, support rod, bow,lever, selection knob

31 Quality of Materials Glass display Stainless steel Plastik foil Stainless steel Plastic Lower part not made of stainless steel, maybe chrome

32 Millipore copied some features from Sartorius to improve their pump design i.e. drainage container, no ventilation anymore Positive for customers: No ventilation anymore Pressure control by pressure sensors (but needs yearly to be calibrated -> Service costs Reduced height compared to predecessor Equinox Optical attractive design of display and display function

33 Conclusion of the Short Overview (1) Feature Sterisart Universal Pump Steritest Symbio Pump (Isolator version) External Box for Power Supply Pump versions Not needed, one more which needs extra space and cable Same pumps can be used for operation in clean bench and Isolator -> highest flexibility Yes, mandatory Customer has to decide upfront where he wants to use it

34 Conclusion of the Short Overview (2) Feature Sterisart Universal Pump Symbio Merck Millipore Display adjustable in angle and height Removeable Display with Plug Yes, very flexible and adjustable for every operator for best working condition yes No, and only limited in angle, limited flexibility for the technician No, fixed installed. Customers needs (worst case) to sent the pump in for exchanging the cable (re-qualification of Isolator the needed)

35 Conclusion of the Short Overview (3) Feature Sterisart Universal Pump Symbio Merck Millipore Barcode Scanner Yes, integrated in 16420, scanning of all used materials (Sterisart consumables, Nutrient media, Rinsing fluids for best traceability and human error prevention) Touch Screen Yes. Covenient operation of the pump. No. Traceability only given by writing the article code, lot and individual number on paper. High risk of transferring wrong codes. No. Operation of the pump by a selection knob only.

36 Conclusion of the Short Overview (4) Feature Sterisart Universal Pump Symbio Merck Millipore Flexibility to use Sartorius consumables and Millipore consumables Additional Box for Software needed Yes. Customer can decide which consumables he wants to use. Also second supplier possible -> Risk mitigation List Price (Euro) Very attractice price even for Isolator manufacturers no No. Customer needs to purchase Millipore consumables. No second supplier possible -> High risk of failure in delivery Yes. Again one more box neccessary which also needs space somewhere