MDI. Recommended Equipment

Size: px

Start display at page:

Download "MDI. Recommended Equipment"

Camron Welch
5 years ago
Views:

1 1 x DUSA for MDIs (Silicone Seals) 1 x Base Plate MDI 1 x DUSA for MDIs (Silicone Seals) 9 x Spare Collection Tubes for MDIs 18 x Spare Rinsing Caps for MDIs 1 x Stand for 10 Collection Tubes 1 x Waste Shot Collector WSC2 1 x Base Plate with Switching Valve 1 1 x 28.3 L/min ACI + Induction Port (A, S or T) + Flow Meter Adapter or 1 x NGI + Induction Port + Flow Meter Adapter or 1 x MSLI + Induction Port (A, S or T) + Flow Meter Adapter (Not accepted by FDA) or 1 x GTI (2-Stage, Ph.Eur. Only) (or GTI Mouthpiece Adapter for GTI) 1 x 28.3 L/min ACI + Induction Port (S) + Flow Meter Adapter + Mouthpiece Adapter or 1 x NGI + 3 x Induction Port + 1 x Flow Meter Adapter + 2 x Spare Cup Trays + 2 x Spare Sets of Cups + 3 x Mouthpiece Adapter Essential 1 x LCP5 ( or HCP5 if also likely to test DPIs sometime in future) 1 x DFM3 or DFM x Pack of Filters (for DUSA/ACI/MSLI) 1 x Pack of Seals (for DUSA/ACI/NGI) 1 x CITDAS Data Analysis Software (excl. GTI) 1 x Leak Test Kit LTK2 for ACI/MSLI (or NGI Leak Tester for NGI) 1 x IQ/OQ Documentation + Additional Tools for ACI/MSLI (or LTK2 + Additional Tools for NGI) 1 x DUSA Shaker (Highly ) + Document + Tools 1 x NGI Gentle Rocker (Highly ) + Document + Tools 1 x Sample Preparation Unit (SPU) + Document + Tools 1 x ASRS/NSRS/NGI Assistant/Induction Port Rinser 3. Minimum equipment for Dose Uniformity of MDIs assumes that customer has alternative method to WSC2 for Waste Shote Collection (e.g. Filtered Fume Hood) 1

2 MDI + Spacer/Valved Holding Chamber (VHC) 1 x Filter Holder and Adapter 1 x BRS 1100 (Neonatal, Infant, Child and Adult 1 & 2 Profiles) + Document + Tools 1 x Filter Holder and Adapter 1 x BRS 1100 (Neonatal, Infant, Child and Adult 1 & 2 Profiles) + Qualfication Document + Tools 1 x 28.3 L/min ACI + Induction Port (A, S or T) + Flow Meter Adapter or 1 x NGI + Induction Port + Flow Meter Adapter or 1 x MSLI + Induction Port (A, S or T) + Flow Meter Adapter (Not accepted by FDA) 1 x 28.3 L/min ACI + Induction Port (S) + Flow Meter Adapter + Mouthpiece Adapter or 1 x NGI + 3 x Induction Port + 1 x Flow Meter Adapter + 2 x Spare Cup Trays + 2 x Spare Sets of Cups + 3 x Mouthpiece Adapter Essential 1 x LCP5 ( or HCP5 if also likely to test DPIs sometime in future)* 1 x BAC 2000* 1 x DFM3 or DFM 2000* * Equipment Only 1 x Pack of Filters (ACI/MSLI) 1 x Pack of Seals (ACI/NGI) 1 x Pack of Filters (for Filter Holder & Adapter, for BRS 1100) 1 x CITDAS Data Analysis Software 1 x Leak Test Kit LTK2 for ACI/MSLI (or NGI Leak Tester for NGI) 1 x IQ/OQ Documentation + Additional Tools for ACI/MSLI (or LTK2 + Additional Tools for NGI) 1 x BAC2000/TPK/TPK 2000 Flow Time Verification Kit 1 x NGI Gentle Rocker (Highly ) + Document + Tools 1 x Sample Preparation Unit (SPU) + Document + Tools 1 x ASRS/NSRS/NGI Assistant/Induction Port Rinser 2

3 1 x DUSA for DPIs (Silicone Seals) 1 x Base Plate DPI 1 x DUSA for DPIs (Silicone Seals) 1 x Base Plate (for single-dose DPIs only) 9 x Spare Collection Tubes without P1 Port for DPIs (or 10 if DUSA Shaker to be used) 18 x Spare Rinsing Caps for DPIs 1 x Stand for 10 Collection Tubes 1 x Waste Shot Collector WSC2 (for multiple-dose DPIs only) 1 x Base Plate with Switching Valve (for multiple-dose DPIs only) 10 x Mouthpiece Adapter (or 11 if WSC2 used) 1 x 28.3 L/min ACI + Induction Port /60/90 L/min Preseparators + 60/90 L/min Conversion Kits (A, S or T) + Flow Meter Adapter or 1 x 28.3 L/min ACI + Induction Port L/min Preseparators (A, S or T) + Flow Meter Adapter (only if 4 kpa is known to = L/min) or 1 x 60 L/min ACI + Induction Port + 60 L/min Preseparator (A,S or T) + Flow Meter Adapter (only if 4 kpa is known to = L/min) or 1 x 90 L/min ACI + Induction Port + 90 L/min Preseparator (A,S or T) + Flow Meter Adapter (only if 4 kpa is known to = L/min) or 1 x NGI + Induction Port + Preseparator + Flow Meter Adapter or 1 x MSLI + Induction Port (A, S or T) + Flow Meter Adapter (Not accepted by FDA) or 1 x GTI (2-Stage, Ph.Eur. Only) (or GTI Mouthpiece Adapter for GTI) 1 x NGI + 3 x Induction Port + 3 x Preseparator + 1 x Flow Meter Adapter + 2 x Spare Cup Trays + 2 x Spare Sets of Cups 3 x Mouthpiece Adapter Essential 1 x HCP5 ( or 2 x HCP5 or 1 x SCP5 if using NGI at Q > 80 L/min) 1 x TPK or TPK 2000 or TPK-R or TPK 2000-R (excl. for GTI) 1 x DFM3 or DFM x Pack of Filters (for DUSA/ACI/MSLI) 1 x Pack of Seals (for DUSA/ACI+Preseparator/NGI+Preseparator) 1 x CITDAS Data Analysis Software 1 x Leak Test Kit LTK2 for ACI/MSLI (or NGI Leak Tester for NGI) 1 x Antistatic Grounding Kit + Electrostatic Eliminator 1 x IQ/OQ Documentation + Additional Tools for ACI/MSLI (or LTK2 + Additional Tools for NGI) 1 x BAC2000/TPK/TPK 2000 Flow Time Verification Kit 1 x DUSA Shaker (Highly ) + Document + Tools 1 x NGI Gentle Rocker (Highly ) + Document + Tools 1 x Sample Preparation Unit (SPU) + Document + Tools 1 x NGI Cup Coater 1 x ASRS/NSRS/NGI Assistant/Induction Port Rinser/Preseparator Rinser 3. Minimum equipment for Dose Uniformity of multiple-dose DPIs assumes that customer has alternative method to WSC2 for Waste Shote Collection (e.g. Filtered Fume Hood) 3

4 N/A (Spray directly into vial) Nasal Spray N/A (Spray directly into vial) 1 x 28.3 L/min ACI + Clamp and Adapter (A, S or T) + Expansion Chamber to Flow Meter Adapter (FDA Only) 1 x 2000 ml Glass Expansion Chamber or 1 x 5000 ml Glass Expansion Chamber (for Nasal Sprays with large plume) or 1 x NGI + Flow Meter Adapter (Not in USP/Ph.Eur. or FDA) or FSI L/min Insert + Expansion Chamber to Flow Meter Adapter (Not in USP/Ph.Eur. or FDA) or GTI + Nasal Modification (Ph. Eur. Only) 1 x Nosepiece Adapter (or GTI Mouthpiece Adapter for GTI Nasal Modification) 1 x 28.3 L/min ACI + Clamp and Adapter (S) + Expansion Chamber to Flow Meter Adapter (FDA Only) 1 x 2000 ml Glass Expansion Chamber or 1 x 5000 ml Glass Expansion Chamber (for Nasal Sprays with Large Plume) Quick Clamp Essential 1 x Nasal Spray Nosepiece Adapter 1 x LCP5 (or HCP5 if also likely to test DPIs sometime in future) 1 x DFM3 (or DFM 2000) 1 x Pack of Filters (for ACI/FSI) 1 x Pack of Seals (for ACI/NGI/FSI) 1 x Leak Test Kit LTK2 for ACI/MSLI (or NGI Leak Tester for NGI/FSI) 1 x IQ/OQ Documentation + Additional Tools for ACI/MSLI (or LTK2 + Additional Tools for NGI/FSI) 1 x NGI Gentle Rocker (Highly ) + Document + Tools 1 x ASRS/NSRS/NGI Assistant 4

5 1 x DUSA for MDIs (Silicone Seals) (FDA Only) 1 x Base Plate Nasal Aerosol 1 x DUSA for MDIs (Silicone Seals) (FDA Only) 9 x Spare Collection Tubes for MDIs 18 x Spare Rinsing Caps for MDIs 1 x Stand for 10 Collection Tubes 1 x Waste Shot Collector WSC2 1 x Base Plate (with Switching Valve) 1 1 x 28.3 L/min ACI + Clamp and Adapter (A, S or T) + Expansion Chamber to Flow Meter Adapter (FDA Only) 1 x 1000 ml Glass Expansion Chamber or 1 x NGI + Flow Meter Adapter (Not in USP/Ph.Eur. or FDA) or FSI L/min Insert + Expansion Chamber to Flow Meter Adapter (Not in USP/Ph.Eur. or FDA) or GTI + Nasal Modification (Ph. Eur. Only) 1 x Nosepiece Adapter (or GTI Mouthpiece Adapter for GTI Nasal Modification) 1 x 28.3 L/min ACI + Clamp and Adapter (S) + Exapnsion Chamber to Flow Meter Adapter (FDA Only) 1 x 1000 ml Glass Expansion Chamber Quick Clamp 1 x Nasal Aerosol Nosepiece Adapter Essential 1 x LCP5 (or HCP5 if also likely to test DPIs sometime in future) 1 x DFM3 (or DFM 2000) 1 x Pack of Filters (for DUSA/ACI/FSI) 1 x Pack of Seals (for DUSA/ACI/NGI/FSI) 1 x Leak Test Kit LTK2 for ACI/MSLI (or NGI Leak Tester for NGI/FSI) 1 x IQ/OQ Documentation + Additional Tools for ACI/MSLI (or LTK2 + Additional Tools for NGI/FSI) 1 x DUSA Shaker (Highly ) + Document + Tools 1 x NGI Gentle Rocker (Highly ) + Document + Tools 1 x ASRS/NSRS/NGI Assistant 3. Minimum equipment for Dose Uniformity of Nasal Aerosols assumes that customer has alternative method to WSC2 for Waste Shote Collection (e.g. Filtered Fume Hood) 5

6 Nebulizer 1 x Filter Holder and Adapter 1 x BRS 1100 (Neonatal, Infant, Child and Adult Profiles) + Angle Adapter + Qualfication Document + Tools 1 x Filter Holder and Adapter + Angle Adapter 1 x BRS 1100 (Neonatal, Infant, Child and Adult Profiles) + Qualfication Document + Tools or 1 x BRS 2000 (Any user defined profile up to 900 ml Volume) + Document + Tools 1 x NGI + Induction Port + Internal Filter Holder + Flow Meter Adapter 1 x 3-Way Valve or 1 x GTI (2-Stage, Ph.Eur. Only) (or GTI Mouthpiece Adapter for GTI) 1 x NGI + 3 x Induction Port + 1 x Flow Meter Adapter + 3 x Internal Filter Holders + 2 x Spare Cup Trays + 2 x Spare Sets of Cups 1 x NGI Cooler + Document + Tools 1 x BAC x Mouthpiece Adapter Essential 1 x LCP5 (or HCP5 if also likely to test DPIs sometime in future)* 1 x DFM3 (or DFM 2000)* * Equipment Only 1 x Pack of Filters (for Filter Holder/NGI Internal Filter Holder) 1 x Pack of Seals (for NGI/NGI Internal Filter Holder) 1 x CITDAS Data Analysis Software 1 x NGI Leak Tester 1 x IQ/OQ Documentation + Leak Test Kit LTK2 + Additional Tools 1 x BAC2000/TPK/TPK 2000 Flow Time Verification Kit (only if BAC 2000 purchased) 1 x NGI Gentle Rocker (Highly ) + Document + Tools 1 x NSRS/NGI Assistant/Induction Port Rinser 6

7 1 x BRS 3000 Adapter for use with DUSAs for MDIs and DPIs IVIVCs 1 x BRS 3000 Adapter for use with DUSAs for MDIs and DPIs 1 x ACI Mixing Inlet (if using ACI, MSLI or FSA) or 1 x NGI Mixing Inlet (if using NGI or FSI) 1 x BRS 3000 Flow Control Manifold for Mixing Inlet - 6 mm (if using 6 mm compressed air line) or 1 x BRS 3000 Flow Control Manifold for Mixing Inlet - 1/4 inch (if using 1/4 inch compressed air line) 1 x Adult/Child Alberta Idealised Throat (A/C AIT) + ACI/FSA Adapter + A/C AIT Flow Meter Adapter + A/C Leak Test Cap & Adapter (if using ACI Mixing Inlet) or 1 x Adult/Child Alberta Idealised Throat (A/C AIT) + NGI/FSI Adapter + A/C AIT Flow Meter Adapter + A/C Leak Test Cap & Adapter (if using NGI Mixing Inlet) 1 x ACI Mixing Inlet (if using ACI, MSLI or FSA) or 1 x NGI Mixing Inlet (if using NGI or FSI) 1 x BRS 3000 Flow Control Manifold for Mixing Inlet - 6 mm (if using 6 mm compressed air line) or 1 x BRS 3000 Flow Control Manifold for Mixing Inlet - 1/4 inch (if using 1/4 inch compressed air line) 1 x Adult AIT Mouthpiece Adapter (if using Adult AIT) Essential 1 x BRS 3000 (+ Laboratory compressed air source capable of delivering 100 L/min at > 2 bar pressure, if performing particle size measurements with Mixing Inlet) 1 x Spare Seal (for Alberta Idealised Throat) 1 x Accessory Support Stand for BRS x BRS 3000 Document + Kit 1 x Real-Time Breath Profile Verification Chamber (optional and only suitable for ACI/MSLI Induction Port) 2. Table assumes customer already has at least the minimum required equipment for Dose Uniformity and/or of MDIs and/or DPIs (see other tabs) 3. Applies to MDIs and DPIs only 7

8 1 x Glass Sample Collection Apparatus for FP Aerosol Fluticasone Propionate Inhalation Aerosol 1 x Glass Sample Collection Apparatus for FP Aerosol 1 x Waste Shot Collector WSC2 1 x Base Plate with Switching Valve 1 x 28.3 L/min ACI + FP Inlet Cone + FP Induction Port (A or S) + FP Flow Meter Adapter 1 x 28.3 L/min ACI + FP Inlet Cone + FP Induction Port (S) + FP Flow Meter Adapter Essential 1 x LCP5 ( or HCP5 if also likely to test DPIs sometime in future) 1 x DFM3 or DFM x Pack of Filters (for ACI) 1 x Pack of Seals (for ACI) 1 x CITDAS Data Analysis Software 1 x Leak Test Kit LTK2 for ACI 1 x IQ/OQ Documentation + Additional Tools 1 x Sample Preparation Unit (SPU) + Document + Tools 1 x ASRS 3. Minimum equipment for Dose Uniformity of FP Inhalation Aerosol assumes that customer has alternative method to WSC2 for Waste Shote Collection (e.g. Filtered Fume Hood) 8

9 1 x Glass Sample Collection Apparatus for FP Powder Fluticasone Propionate Inhalation Powder 1 x Glass Sample Collection Apparatus for FP Powder 1 x Waste Shot Collector WSC2 (for multiple-dose DPIs only) 1 x Base Plate with Switching Valve (for multiple-dose DPIs only) (or 2 if WSC2 used) 1 x 28.3 L/min ACI + FP Preseparator + FP Induction Port (A or S) + FP Flow Meter Adapter 1 x 28.3 L/min ACI + FP Preseparator + FP Induction Port (S) + FP Flow Meter Adapter Essential 1 x HCP5 1 x BAC 2000 (or TPK or TPK 2000 or TPK-R or TPK 2000-R if also likely to test other DPIs sometime in future) 1 x DFM3 or DFM x Pack of Filters (for SCA/ACI) 1 x Pack of Seals (for ACI+Preseparator) 1 x CITDAS Data Analysis Software 1 x Leak Test Kit LTK2 for ACI 1 x Antistatic Grounding Kit + Electrostatic Eliminator 1 x IQ/OQ Documentation + Additional Tools 1 x BAC 2000/TPK/TPK 2000 Flow Time Verification Kit 1 x Sample Preparation Unit (SPU) + Document + Tools 1 x ASRS 3. Minimum equipment for Dose Uniformity of multiple-dose DPIs assumes that customer has alternative method to WSC2 for Waste Shote Collection (e.g. Filtered Fume Hood) 9

Product Guide. MSP Corporation Rice Creek Parkway, Suite 300. Shoreview, Minnesota 55126, U.S.A. Phone: Fax:

Product Guide. MSP Corporation Rice Creek Parkway, Suite 300. Shoreview, Minnesota 55126, U.S.A. Phone: Fax: Product Guide inhalertesting MSP Corporation 5910 Rice Creek Parkway, Suite 300 Shoreview, Minnesota 55126, U.S.A. Phone: 651.287.8100 Fax: 651.287.8140 sales@mspcorp.com www.mspcorp.com About This Guide