Compressed Medical Gases Guideline, 2/89 (cmgg89.htm)
...The manifolds are equipped with fill connections that correspond only to the container valve.....A visual external inspection of each valve and container for dents, arc burns, other damage, and oil.....The use of manifold and container valve connections recommended in the Compressed Gas..
http://www.fda.gov/cder/guidance/cmgg89.htm (score=100)

...Container and Closure System Nasal aerosols usually consist of the formulation, container, valve.....SMALLER CONTAINER SIZES Nasal aerosols and nasal sprays may be available in two container.....If this is infeasible, we recommend that valve, pump, and actuator designs be as close as..
http://www.fda.gov/cder/guidance/5383DFT.doc (score=40)

BA/BE studies for Nasal Aerosols and Nasal Sprays for Local Ac
...Nasal aerosols consist of the formulation, container, valve, actuator, dust cap.....components and composition, metering valve, and actuator as the large container size that.....which the reference product labeling recommends storage in the valve down position..
http://www.fda.gov/cder/guidance/2070dft.pdf (score=40)

MDI and DPI Drug Products
...Documentation in Drug Applications for Container and Closure Systems Used for the.....stem orifice of the valve, the vapor pressure in the container, and the nature of the.....drug substance, optimized formulation, valve and actuator design, 89.. manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=14)

Acidified food manufacturers
...Are container examinations made as per the container manufacturer specifications and or.....c) Is the pressure reducer valve set properly to supply correct pressure and steam flow to.....Another example is improper container closure resulting in contamination with..
http://www.fda.gov/ora/inspect_ref/igs/acidfgde.htm (score=14)

Packaging
...Complete construction, composition, and description of all component parts of valve closure and container.....When drugs are administered by means of an aerosol dosage form, the valve closure system.....A suitable closure is an essential part of the container/closure system required to..
http://www.fda.gov/cder/guidance/package.htm (score=14)

Guidance for Industry
...valve assembly, the acceptability of the valve packing and the valve seal used, the type.....container and attached it to the container containing argon, and was able to fill the.....would examine whether any of the threads on the valve or on top of the valve stem are..
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0165-gdl0001.pdf (score=14)

FDA Concept Paper: Drug Products That Present Demonstrable Difficulties for...
...The aerosol dispenser consists primarily of a metal or glass container, a valve assembly, and an.....In MDI products, the container closure system consists of the container, the valve and its components.....In addition, a product filler capable of reproducing an exact fill amount from container to container..
http://www.fda.gov/cder/fdama/difconc.htm (score=14)

Fresh Air '2000' A look at FDA's Medical Gas Requirements
...problems associated with the valve, the valve seal material, ejection of valve stems, the container whether.....At this time, each cylinder valve assembly is tested for valve packing leaks, safety plug leaks and other valve leaks.....This would pertain to any container or closure used to deliver industrial products, any..
http://www.fda.gov/cder/dmpq/freshair.htm (score=12)

...CONTAINER MAY OCCUR WITH PRODUCTS | |DESIGNED TO STACK ON STORE SHELVES E.G. TUNA.....VALVE) IS USED TO ENHANCE WATER ENTRY| |INTO THE PROCESSING VESSEL; | |IS AN AIR PURGE.....CONTAINER SIZE COVERED DURING THE INSPECTION. | |COMPUTER CONTROLS | |DOES A COMPUTER..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511E.DOC (score=12)

...HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH | |CONTAINER HOLDING.....Note-the following parameters (Retort installation, come up | |procedures, container type, container size, container.....REPORT THE MANUFACTURER, MODEL, TYPE AND SIZE OF THE AUTOMATIC | |STEAM CONTROL VALVE..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511H.DOC (score=12)

...IF MORE THAN ONE CONTAINER SIZE OR TYPE IS PROCESSED AT ONE TIME, | |DESCRIBE PROCEDURE.....REPORT THE MANUFACTURER, MODEL, TYPE AND SIZE OF THE AUTOMATIC STEAM | |CONTROL VALVE.....YES[] NO[] | |HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH CONTAINER..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511I.DOC (score=12)

...PRESSURE RELIEF VALVE | |IS THE RETORT EQUIPPED WITH AN ADJUSTABLE PRESSURE RELIEF OR.....STACKING EQUIPMENT AND CONTAINER POSITION (113.40(b)(7) | |ARE CRATES, TRAYS, ETC. FOR.....REPORT THE MANUFACTURER, SIZE, MODEL AND TYPE OF AUTOMATIC STEAM CONTROL | |VALVE..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511B.DOC (score=12)

fd2400a1
...Insert tip into agitated sample in rigid container, or poured.. (SPLC/area) into sterile 5.....open the valve for 5 seconds. Close the valve. Allow.. a. Prepare or melt agar quickly in.....Remove the valve from syringe, insert hand held.. 13. Acid cleaner, 0.5 N sulfuric acid..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA-2400a-1.pdf (score=12)

...IF MORE THAN ONE CONTAINER SIZE OR TYPE IS PROCESSED AT ONE TIME DESCRIBE| |PROCEDURE USED.....REPORT THE MANUFACTURER, MODEL, TYPE AND SIZE OF THE AUTOMATIC STEAM | |CONTROL VALVE.....YES[] NO[] | |HAS A TEMPERATURE DISTRIBUTION STUDY BEEN PERFORMED ON EACH CONTAINER..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511G.DOC (score=12)

...container. This reel speed may be the same as that established to | |provide for process.....The approximate | |number of reel steps for the FMC system for each container size is.....VALVE? | |IF THE TEMPERATURE (STEAM) CONTROLLER IS AIR OPERATED, DOES THE SYSTEM | |HAVE..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511C.DOC (score=12)

New Device Approvals - Mentor Alpha I Inflatable Penile Prosthesis - P000006
...To get his penis erect, a man squeezes the pump to send fluid from the container to..the.....valve and let fluid flow back to the container. When is it used? This device is used when..
http://www.fda.gov/cdrh/mda/docs/p000006.pdf (score=12)

...IN THE STEAM CHAMBER BETWEEN THE STEAM-WATER INTEFACE AND THE LOWEST | |CONTAINER POSITION.....REPORT THE MANUFACTURER, MODEL, TYPE AND SIZE OF THE AUTOMATIC STEAM | |CONTROL VALVE.....40(f)(8) | |IS THE SPEED OF THE CONTAINER CONVEYOR CHAIN SPECIFIED IN THE SCHEDULED..
http://www.fda.gov/opacom/morechoices/fdaforms/FDA3511F.DOC (score=12)

ENFORCEMENT REPORT FOR July 23, 2003
...9% Sodium Chloride Injection, USP, 100 mL, ADDS Unit Single-dose container, For I.V. use.....Inch; b) LifeShield Latex-Free Pressure Activated Valve .. Extension Set with Locking Spin.....PlumSet, Convertible Pin, 105 Inch; u) Latex-Free Enteral PlumSet with Integral Container..
http://www.fda.gov/bbs/topics/enforce/2003/ENF00805.html (score=12)

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