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Capitol,
an IS0 9001 company, manufactures sterile, tamper-evident,
air-tight, leak-proof, clarified polypropylene vials
that feature easy one-hand opening and closing.
They are manufactured in FDA approved Class 10,000
clean rooms, and laboratory proven (NIDA lab tested).
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****************************** *Sample
transport vial
******************************* Automated
aliquot workstation
******************************* Vial
sample kit
******************************* Vial
disposal and recycling system
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INNOVATIVE
PLASTIC CONTAINERS
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| Capitol
Vial, Inc. is a vertically integrated ISO 9001-certified
manufacturer of one-piece plastic containers. Patented
molding technology enables Capitol Vial, Inc. to produce
containers that are airtight, leak-proof, and sterile
by process. All of Capitol Vial's molds are designed
and built in-house to meet exacting specifications.
Utilizing the latest Wire and RAM EDM technology, molds
are built within .0005" tolerance. In addition
to tooling capabilities, Capitol Vial can apply engineering
expertise to integrate its container technology into
both customers' and in-house high speed packaging lines.
This integration provides customers with turnkey solutions
to their unique packaging applications. Taking advantage
of strengths in the areas of tool design, mold building,
manufacturing, and packaging, Capitol Vial, Inc. has
become a leading provider for the pharmaceutical, medical
device, diagnostic testing, drug testing, water testing,
health care, food, dairy, and confectionery industries.
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| Capitol
Vial Three Seal Design |
| Figure
#1 illustrates the critical aspects of the three
seal design. The figure also depicts the position
of the lid as it approaches the container during
closing. The hinged design positions the lid at
the appropriate angle to ensure proper closure. |
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| The
first seal is formed by the union of the lid valve
(Figure #2) with the inside surface of the container
wall. The integrity of this seal is obtained by
forcing the top of the container into a small
space between the valve and the wall of the lid.
The structural interference encountered during
closing and the shrinkage that occurs during the
curing stage create the airtight seal. |
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| The
second seal is formed by the union of the top
edge of the container wall (Figure #3) and the
inside wall of the lid. Similar to the first seal,
it is a combination of structural interference
and shrinkage that guarantees the integrity of
the seal. This feature's primary function is to
provide a leak proof seal that prevents fluids
from entering or exiting the container. |
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| The
third seal is formed by the union of the outer
wall of the container (Figure #4) and the undercut
around the inside wall of the lid. This seal provides
the another layer of protection against fluid
ingress and egress and also determines the amount
of internal air pressure the container will withstand.
The level of internal air pressure is controlled
by the ratio of surface contact to undercut. |
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| Molding
and Curing |
The
critical aspect of Capitol Vial’s injection
molding technology is its ability to close the
container before the material is fully set. By
closing the container while the part is still
hot, Capitol Vial, Inc. uses the natural curing
properties of the plastic to help form the seals
inherent in the container design. The process
for closing the container in the mold is shown
in the figures below. The mold consists of two
sides, the cavity and the core. The container
can be closed in the mold because the cavity that
forms the lid is located in a movable piece of
the mold called the flipper. Plastic is injected
into the mold from the bottom of the body cavity
and forms around the cores. The hinge of the container
provides the pathway for the plastic to flow from
the body to the lid cavity. As depicted in Step
1, the container remains in the cavity after the
cores have retracted. This differs from many injection
molding processes where the part is usually removed
from the cavity by the retracting core.
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| With
the core side retracted, the flipper is free to
rotate upwards. Step 2 illustrates the flipper
moving the lid towards the body of the container.
The flipper rotates 180º until the lid is
closed onto the body of the container. Since the
container is still hot, the plastic flexes and
allows the seal to form without distortion. |
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| As
the flipper returns to its home position in Step
3, the lid is secured to the body of the container
and the normal shrinkage process continues. Along
with the airtight seals, shrinkage also creates
the “living hinge” of the container.
The hinge is molded in the open position and as
a result acquires memory for this orientation.
The hinge also obtains memory in the closed position.
This “dual memory” creates a robust
“living hinge” which maintains its integrity
indefinitely. |
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| Once
the flipper is fully retracted, the container
is ejected from the mold in Step # 4 with the
use of a mechanical pin and air pressure. The
container continues to cool until it reaches ambient
temperature. |
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| Figure
#5 shows the distortion that occurs when the lid
is closed after the material has cooled and has
fully set. Since shrinkage has occurred, the plastic
is less flexible and the first and third seal
areas are distorted upon closure. This distortion
damages the integrity of the seals and prevents
the container from being airtight or leak-proof.
Capitol Vial's unique closing processes prevent
the plastic from cooling excessively before closure
and ensure a perfect seal. |
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| Features
and Benefits |
| One-piece
design Eliminates
tolerance mismatches between bottles and caps
Removes any cross contamination issues
Improves productivity through ease of opening
and closing
Reduces number of inventory items
Cost effective
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| Container
and lid are made of the same material
Container
and lid have the same coefficients of shrinkage
and expansion and will maintain the integrity
of their seal despite large variations in temperature
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| Sterile
by process / FDA /CFR 21 standards Eliminates
need to perform secondary means of sterilization
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Prior to Opening |
| Tamper
evident by process (Pictures at right)
Only
manufacturer that can ensure tamper evidency
as container exits mold
The tamper evident arrow is molded to the body
of the container and is inserted into the arrow
box when the container is closed in the mold.
The arrow separates from the body of the container
and is ejected from the arrow box upon the initial
opening.
Eliminates need to provide secondary means of
tamper evidence |
After Opening
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| Customizable
Able
to make any size, shape, color, or clarity
Easy to emboss, engrave, label, and silk-screen
Child-proof closures
Chain of custody closures
Additional snap seal or locking tab closures
can be added to eliminate accidental opening
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Compatible
with Activ-Pak™ family of products
Create
uniform environment inside of container (e.g.
RH) |
| Environmentally friendly / 100 %
recyclable |
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| Leak
proof / airtight (approximately 100 micrograms a day
depending on size and style of container - see graph)
Improves
safety by eliminating potentially hazardous substances
leaking from container
Maintains product integrity and prolongs shelf-life
Allows container to maintain sterility throughout
life cycle
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| Operational
Practices |
| Capitol
Vial, Inc. is an ISO 9001-certified supplier that manufactures
containers in class 100,000 and class 10,000 clean rooms.
All air in the clean rooms passes through HEPA filters
every 20 minutes to remove particles greater than .5
microns in size. Every room is environmentally controlled
to help reduce machine variability and thus improve
product quality. The
quality system is maintained through strict adherence
to the ISO 9001 standard. Capitol utilizes Statistical
Process Control (SPC) and Statistical Quality Control
(SQC) to quantify variability in its manufacturing
operations. Failure Mode and Effects Analyses (FMEA)
are conducted to develop robust processes and facilitate
continuous improvement. Quality testing consists of
hourly in-process inspections and laboratory analysis.
The laboratory analysis is both quantitative and qualitative.
An interval based sampling plan determines the frequency
of product testing and enables non-conforming product
to be easily isolated. The following tests are conducted
to ensure adherence to product specifications.
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| PROCEDURE: |
PURPOSE: |
| Leak
Detection Testing |
Validates
seals in the container.
Serves as a diagnostic tool by indicating imperfections
in the seal area before product is non-conforming.
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| Opening
Force Place
container top-up into the holding vice and align
the cap under the sensor arm. Activate the cylinder
and read measure gauge at the end of the upward
stroke.
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Measures
the force required to open the container.
Ensures container can be easily opened by anyone.
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| Electronic
Organoleptic Testing Punch
¼ inch hole in lid of container and insert
flexible hose of an electronic nose (Aroma Scan)
into the container. Remove the flexible hose
when test is complete.
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Measure
the volatile odors inside the container.
Ensures containers conform to baseline odor parameters.
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| Moisture
Vapor Transfer Rate Testing (MVTR)
Open
container and place a predetermined amount of
desiccant into the container. Close the container
and place into an environmental chamber (80%
RH @ 72ºF). Weigh the containers at given
intervals and record weight gain.
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Determines
MVTR through the seal and sidewall of the container.
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| Impact
Testing (Drop Testing) Fill
containers with water and place at three different
conditions: (a) room temperature (b) 36ºF
(refrigerator temperature) and (c) 0ºF
(freezer temperature). Drop containers bottom
first and inverted from a 4-foot height. Inspect
containers for damage and record data.
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Determines
the impact strength of the container at different
temperatures.
Ensures containers can withstand impact across
a range of environmental conditions.
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| Microbiological
Testing Swab
inside wall of containers and transfer to growth
agar for enumeration.
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Determines
the sterility of the container.
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| Internal
Pressure Test Invert
container (cap side down) under a water bath
and insert a probe through the sidewall. Inject
air through the probe into the container until
the container shows signs of air leakage in
the water bath. Measure the air pressure with
a calibrated pressure gauge.
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Quantifies
internal air pressure required to break container
seal.
Validates the efficacy of airtight seal
Ensures container meets minimum requirements to
withstand air transport.
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| Continuous
In-line Testing Place
an inert gas (argon) into the container prior
to closing. Measure the amount of escape through
the seal area of the container by using a continuous
in-line measurement system.
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Detects
and rejects any container which does not meet
the airtight specification.
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