CS - Flipcaps CS0270-01

Approval Date : 28.11.
2019
CS Report CS0270-01
Edition : 1.0
General Flip Cap Documentation
Written by:
Ralf Dittmer
Head of R&D Parenteral Packaging Systems
Electronically signed on 27.11.2019
Reviewed by:
Kuehnle, Stefan
Head of Quality Management
Approved by:
Jongen, Bram
Head of R＆D Parenteral Packaging Systems
STANDARD CS REPORT
Datwyler Pharma Packaging International NV, Industrieterrein Kolmen 1519, BE-3570 Alken, Belgium
T +32 11 590 811, F +32 11 314 086, sealing.be@datwyler.com, www.datwyler.com
Scope
This document covers all alu-plastic caps available from Datwyler Sealing Solutions. It does not cover
alu-solo caps. The type-abbreviations and the names of the covered caps are shown in
Table 1
Abbreviation Meaning
FC Flip Cap
SFC Scoreline Flip Cap
FBC Flip Bridge Cap
UTO Universal Tear-Off
Table 1: Caps covered in this document
CS0270-01, Edition 1.0: General Flip Cap Documentation

28.11.2019 Standard CS Report 2/23
Table of Contents
Scope ........................................................................................................................................... 2
Table of Contents ......................................................................................................................... 3
Description.................................................................................................................................... 4
3.1 Functionality description ..................................................................................................................... 4
3.2 Flip Caps (FC) .................................................................................................................................... 5
3.3 Score-line Flip Caps (SFC) ................................................................................................................ 5
3.4 Prime Cap (FBC) ................................................................................................................................ 6
3.4.1 Cap design analysis and machinability trials .................................................................................. 9
3.5 Universal tear off caps (UTO) .......................................................................................................... 11
3.6 Difference between standard and flush design flip caps ................................................................. 11
3.7 Opening forces ................................................................................................................................. 12
3.8 Datwyler product codes for Flip Caps .............................................................................................. 13
3.9 Flip Cap production conditions ......................................................................................................... 13
3.10 Flip Cap storage conditions ............................................................................................................ 14
3.11 Printing on flip caps ........................................................................................................................ 14
Material ingredients .................................................................................................................... 15
4.1 Aluminum.......................................................................................................................................... 15
4.2 Epoxy lacquer ................................................................................................................................... 15
4.3 Polypropylene (PP) .......................................................................................................................... 15
4.4 Lubricants ......................................................................................................................................... 15
4.5 Heavy metals .................................................................................................................................... 16
4.6 Bisphenol A (BPA) ............................................................................................................................ 16
4.7 BSE/TSE .......................................................................................................................................... 16
4.8 ICH Q3D Guideline........................................................................................................................... 16
4.9 Pork and Alcohol .............................................................................................................................. 17
4.10 Phthalates ...................................................................................................................................... 17
4.11 Nonylphenol ethoxylates (NPE) ..................................................................................................... 17
4.12 Octylphenol etoxylates (OPE) ........................................................................................................ 17
4.13 Asbestos ......................................................................................................................................... 18
4.14 Calcium........................................................................................................................................... 18
4.15 Chlorine .......................................................................................................................................... 18
4.16 Polychlorinated and Polybrominated Diphenyl .............................................................................. 18
4.17 Conflict minerals ............................................................................................................................. 18
4.18 Latex, gluten and lactose ............................................................................................................... 18
4.19 Allergens and other substances ..................................................................................................... 19
4.20 Nickel .............................................................................................................................................. 19
Sterilization ................................................................................................................................. 20
5.1 Steam sterilization ............................................................................................................................ 20
5.2 Radiation sterilization ....................................................................................................................... 20
Packaging ................................................................................................................................... 20
Shelf life of flip caps ................................................................................................................... 20
Datwyler Quality level: Alu cap and Flip cap .............................................................................. 20
8.1 Sampling plan ................................................................................................................................... 20
8.2 Defect classification.......................................................................................................................... 21
8.2.1 Critical defects: .............................................................................................................................. 21
8.2.2 Major A defects ............................................................................................................................. 21
8.2.3 Major B defects have a limited risk of: .......................................................................................... 21
8.2.4 Minor defects ................................................................................................................................. 21
8.3 Specifications visual inspection ........................................................................................................ 22
History ........................................................................................................................................ 23

Description
Flip cap seals are used to secure the rubber stopper onto injection vial; infusion bottles as well as IV
funnels and injection ports on IV bags to maintain container closure seal integrity (CCSI).
Caps manufactured by Datwyler Sealing Solutions typically follow the ISO 8362-6, ISO 8362-7
respectively ISO 8536-71 standards. However certain dimensional differences to these ISO standards
may apply. Please check the corresponding product drawing for details.
3.1 Functionality description

The caps are assembled from an aluminum cap and a plastic flip disc. In the case of the UTO cap an
additional inner cap is added to hold the plastic cap. The assembled cap is crimped on an injection vial
or infusion bottle to secure the rubber stopper which in turn maintains the integrity of the
container/closure system. After removing the plastic disc on top of the flip cap, the piercing point in the
rubber stopper is exposed to the injection needle respectively the infusion device or similar. UTO caps
can be completely removed from the vial after opening of the plastic disc.
1
ISO 8362-6 ‘Injection containers and accessories – Part 6: Caps made of aluminum-plastics
combinations for injection vials’
ISO 8362-7 ‘Injection containers and accessories – Part 7: Injection caps made of aluminium-plastics
combination without overlapping plastics part’
ISO 8536-7 ‘Infusion equipment for medical use – Part 7: Caps made of aluminum-plastics
combination for infusion bottles’

3.2 Flip Caps (FC)
FC caps are available in sizes 13, 20, 28 and 32mm. They are assembled from aluminum caps with a
plastic disc. In case of FC the plastic disc is equipped with fingers (amount of fingers varies with
design), see Figure 1. The fingers are folded over by means of pressure and temperature during the
assembly process to attach the plastic disc to the aluminum cap. The advantage of this design is the
intrinsic tamper evidence. During opening of FC caps the plastic is completely separated from the
aluminum which allows easy recycling of the different components.
Figure 1: FC components
3.3 Score-line Flip Caps (SFC)

SFC caps are available in sizes 13 and 20mm. They are assembled from aluminum caps with a plastic
disc. In case of SFC the aluminum cap is equipped with a round pre-scored area which breaks off
during opening of this cap, see Figure 2. The plastic disc is in this case equipped with a short plastic
cylinder which is formed to a rivet, by means of pressure and temperature, during assembly of the
caps. The opening force of this cap is determined by the score-line. Therefore this cap is especially
suitable for sterilization processes.
Figure 2: Score-line flip caps

3.4 Prime Cap (FBC)
Prime caps are available in sizes 13, 13 long, and 20mm. They are assembled from aluminum
capsules with a mechanically affixed plastic disc. The disc is secured to the metal shell by a series of
metal bridges designed to release the plastic disc at the point of use by the user putting upward
pressure on the disc. The flip-off force is designed to be enough to keep the disc in place during filling
and storage but still easily removed at the point of use.
Prime caps are optimally designed to work seamlessly with fill-finish machinery commonly found
globally.
13mm (long) Flip-Bridge Cap

Inner alu cap diameter 13.36±0.05mm
Plastic disc diam. 14.85 ±0.25mm
Total cap height 8.3±0.35mm
Alu skirt length 6.6±0.15mm
Plastic disk surface Matte (FBC13.0003) and
glossy (FBC13.0004)
Aluminum thickness 0.20±0.02mm
Plastic material PP homopolymer food grade
Use of reground PP No
Plastic injection point Inside center
Alu earing Trimmed cap
Cap opening Breaking of alu bridges
Suitable for steam sterilization @121°C for Yes
30min
Suitable for gamma sterilization Yes (only with stabilized PP)
Table 2: Specification for 13mm long FBC
13mm (standard) Flip-Bridge Cap

Plastic disk diam. 14.85±0.25mm
glossy (FBC13.0002)
Alu earing Trimmed cap
30min
Table 3: Specification for 13mm standard FBC
20mm Flip-Bridge Cap

Plastic disk diam. 22.80±0.25mm
glossy (FBC20.0002)

Alu earring Trimmed cap
30min
Table 4: Specification for 20mm standard FBC
Figure 3: 13mm Flip Bridge cap (bottom view)

Figure 2: 13mm Flip Bridge cap (side view)
Figure 3: 20mm Flip Bridge cap (top view)

Figure 4: 20mm Flip Bridge cap (bottom view)
3.4.1 Cap design analysis and machinability trials

An independent parenteral technology consultant completed evaluations and machinability trials of the
13mm (FBC13) and 20mm (FBC20) plastic/aluminum Prime Caps for parenteral drug vials, including
design reviews, basic sealing analyses, and high speed machinability trials.
The design review compared the improved designs to ISO standard 8362-6 and the published
competitive specifications. The improved Datwyler caps meet and surpass all the dimensions and
tolerances of the ISO standard.
Visual examination shows well manufactured components. There is no evidence of edge earing of the
aluminum or flash on the plastic button. The buttons are well affixed to the aluminum. The scoring and
bridges are well designed and manufactured.
Basic sealing studies were conducted on laboratory cappers, using both sealing rail and spinning roller
technologies (spinning roller on 20mm only). Overall good seals were achieved with typical set-ups,
requiring little fine tuning. The visual quality was very good, the seals had good “tuck” with no
wrinkling, folding, waviness, extrusion or tearing. The Residual Seal Force (RSF) values or stopper
compression results were consistent with well-sealed vials. Compression analysis suggest very low
risk of container closure integrity (CCI) failure.
Machinability trials were conducted on an RW600 capper with rail technology. The machine set-up
parameters were those established representing a typical set-up. Both the 13mm and 20mm caps ran
very well, with less than expected interventions or jams. Machine speeds ranged from 250 to 400
vials per minute (VPM), which is considered moderate to high speed. Very high speeds (600-750
VPM) were not tested due to the limitations of the specific machine. Comments from the operators and
technicians were very positive. The visual evaluation and RSF measurements of vials from the
machinability runs were consistent with the laboratory capper trials and can be considered very good.
Overall the caps are very well suited for all typical applications and most others, with certain
consideration given to the variation of the other components. They were seamlessly interchangeable
with other commonly used caps in the North American market. We found the caps and capping to be

very satisfactory, and would anticipate very successful runs and well-sealed vials using those caps on
most equipment.
Caveat: The conclusions are limited by vial and stopper selection. Other choices may yield varying
results. The cappers used in this study, while a market leader, do not represent all cappers. Different
set-ups, hopper and feed systems could present challenges not observed in this study. Full details of
this report are available upon request.

3.5 Universal tear off caps (UTO)
UTO caps are available in sizes 20, 28 and 32mm. They are assembled from two or three
components. The UTO type made with 3 components consist of one aluminum cap with a ring, one
aluminum inner cap and one plastic disc with finger design. The ring on the main aluminum cap allows
for a complete removal of the cap, see the description below. The inner ring is needed in this design to
hold the plastic disc.
The UTO type made from 2 components only consists of an aluminum cap and one plastic disc with a
center rivet, see also Figure 2. After loosening of the plastic disc, the entire cap can be removed.
The opening mechanism of the UTO cap is shown in Figure 5
Figure 4: UTO cap after plastic disc removal
To open a UTO cap flip the plastic disc up and remove it. This will expose the piercing point of the rubber stopper. To completely remove the UTO cap with the
stopper, pull up the metal ring and tear it straight down to break the metal cap. Remove the cap and the smaller inner cap from the stopper. Now the stopper
can be completely removed.
Figure 5: Usage of 3 piece UTO cap
3.6 Difference between standard and flush design flip caps

The standard flip caps as seen in Figure 1 have a plastic disc which overlaps the aluminum cap by a
certain distance. For applications with narrow vials Datwyler also produces flush design flip caps on

which the plastic disc does not overlap the aluminum. This allows more stable transportation of the
capped vials in the filling line.
Figure 6: Flush design flip caps
3.7 Opening forces

The opening forces of Datwyler flip caps follow ISO 8362-7 and ISO 8536-7 and are listed below.
Cap diameter in Maximum opening force

mm in N
13 25
20 35
28 40
32 60
Table 5: Opening forces of flip caps according to ISO 8362-7 resp. 8536-7
Based on testing the opening force of the 13mm Prime Caps was found satisfactory and well within
established compendial and internal specifications. Average flip force value was 15.9N with a low of
14.4N and a high of 17.4N.
The 20mm Prime Caps were tested and found to be satisfactory and within established internal and
compendial specifications. Average flip force value was 15.2N with a low of 13.6N and a high of
17.0N. The Datwyler internal specification for flip force is minimum 8.9 N and a maximum 24.5N.

3.8 Datwyler product codes for Flip Caps
The Flip Caps manufactured by Datwyler Sealing Solutions follow a certain part number coding. The
part number of finger design Flip Caps starts with the abbreviation of the specific cap type like FC,
SFC, FBC, UTO, etc. The next two digits of the part number define the diameter of the flip e.g. 20,
32mm followed by a period (‘.’). The next 4 digits are a sequential drawing number followed by a
space and a 6 digit color code of the aluminum. The following 4 digit color code of the plastic disc is
again separated by a space from the preceding number.
Example of Datwyler product code for Flip Caps:

Aluminum color code
Diameter of the cap
SFC20.0001 001000 6002

Plastic disc color code
Cap design (FC or SFC)
Drawing number
3.9 Flip Cap production conditions

All Flip Cap production plants of Datwyler Sealing Solutons are certified according to ISO 9001 and in
certain cases also ISO 15378. An up to date list of the current certifications of each production plant
can be found on the website of Datwyler Sealing Solutions.
Datwyler flip caps are produced with dedicated, fully automatic, high-speed assembly machines
according to specific diameter of the caps. All caps are controlled by a 2 color camera inspection
system. The capabilities of the camera systems can be viewed in CS0374-01.

3.10 Flip Cap storage conditions
Aluminum/plastic caps used for the capping of container/closure systems of parenteral
pharmaceuticals are typically manufactured from epoxy lacquer coated aluminum and polypropylene
(PP). The physical and functional properties of polymers (epoxy, PP) change over time. This ageing
may be accelerated by inappropriate storage conditions.
Temperature, humidity, oxygen, ozone and light are factors, alone or in combination that may cause
accelerated ageing in polymers.
The effects of these factors may be minimized by proper storage conditions.

The following guidelines may be useful in assuring the quality and functionality of aluminum and
aluminum/plastic caps over time.
 Protection from oxygen and ozone: Typically aluminum and aluminum/plastic caps are packed
in plastic bags. The caps should remain in their original packaging unopened until they are
ready to be used.
 Protection from light: Aluminum and aluminum/plastic caps should remain in the bags in the
unopened boxes. If removed from the box, the caps must be protected from exposure to
sunlight and strong artificial light with a high ultra-violet content.
 Protection from temperature extremes: Storage at ambient temperatures are recommended.
Permanent exposure to high temperatures may accelerate degradation. Lower temperatures
will lead to temporarily increased brittleness of the parts.
 Protection from moisture: Wet and high humidity conditions should be avoided. Storage
conditions must be such that condensation does not occur.
 Protection from deformation: Compression will cause caps to deform. Boxes should be
stacked to utilize the strength of the corrugate to avoid compression of stored caps.
 Protection from other materials: Aluminum and aluminum/plastic caps should not have contact
with solvents or their vapors or other chemicals. Caps should be stored away from chemical
ingredients. The warehouse should be sufficiently ventilated.
Storage times should be minimized, first-in/first-out usage of stocks is highly recommended.
3.11 Printing on flip caps

Flip Caps are assembled from a deep drawn aluminum cap and a plastics disc made from PP
polymer. Lubrication is applied on the aluminum for the deep drawing process, while PP by itself has a
low surface tension. Both factors could make printing on the flip caps challenging. Pre-treatment
(plasma, flame, …) of the Flip Caps could elevate the surface tension of the product to allow better ink
adhesion. However, Datwyler has not tested the effect of pre-treatments on the quality or functionality
of the Flip Caps.
It is therefore not recommended to print on the surface of flip caps. In any case thorough testing has to
be performed by the user of the flip caps prior to printing or pre-treatment of the caps.
Datwyler can offer printed caps that were pre-treated for proper ink adhesion.

Material ingredients
4.1 Aluminum
Datwyler Sealing Solutions uses aluminum alloys that meet the specification of EN ISO 8872, for the
production of flip caps. The alloy specifications of EN ISO 8872 is shown in Table 6.
Alloy Tensile strength Yield strength in MPa
(UTS) in MPa
AlFeSi (annealed or 100 – 150 > 80
coated)
AlFeSi 130 – 170 > 110
AlMnCu 140 – 180 > 120
The alloys above present only a selection of alloys typically used for the
manufacturing of aluminum flip caps. Other alloys are permitted providing
they meet the mechanical properties in this table.
Table 6: Mechanical properties of aluminum alloys according to ISO 8872
4.2 Epoxy lacquer

The aluminum used for the manufacturing of flip caps is typically lacquered with epoxy based lacquer.
This lacquer is, with one exception (see below), in compliance with the following regulations:
 Europe: 2007/19/CE, 2023/2006/CE

 Germany: BGA
 USA: FDA 21 § 175.300
Depending on customer specifications the lacquer may be pigmented for coloration. The lacquer
application per square meter is fixed but may vary depending on color of the lacquer.
Black lacquer does not fulfill the above compliances due to the necessary amount of carbon black in
the lacquer.
4.3 Polypropylene (PP)
PP homopolymer is used for the manufacturing of the flip disc. The used PP compounds
meet the requirements on materials and articles intended for contact with foodstuffs
according to Regulation (EC) 1935/2004 of the European Parliament and of the Council, as
well as according to Commission Regulation (EU) No 10/2011 including changes and
additions.
4.4 Lubricants
The lubricants used for the manufacturing of the aluminum caps are in compliance with FDA CFR 21 §
178.3910. The level of remaining lubricants, on the product, does not exceed the level of 0.2 mg/inch²
(0.031 mg/cm²).

4.5 Heavy metals
Flip Caps manufactured by Datwyler Sealing Solutions fulfil the European Community Guideline CEE
94/62 for heavy metals in packaging materials and the CONEG Regulation on Reduction of Toxics in
Packaging Law.
Both directives state that packaging components should not contain more than 100 ppm of Lead (Pb),
Cadmium (Cd), Mercury (Hg) and Hexavalent Chromium (VI) (Cr).
4.6 Bisphenol A (BPA)

Bisphenol A, CAS# 80-05-7 is used to produce certain plastics and epoxy resins. Epoxy resins
containing BPA are used as coatings on the inside of many food and beverage cans as well as a
coating for the aluminum used for the manufacturing of flip caps. BPA is mostly consumed during the
curing (polyaddition) of the lacquer.
Datwyler Sealing Solutions conducted an extraction study on epoxy lacquered aluminum caps of one
specific color in June of 2012. Thermal Desorption – Gas Chromatography / Mass Spectroscopy (TD-
GC/MS) was used for this study. As a result, under the conditions of the test, BPA was found at a level
of only 0.02µg/cm² of lacquered surface in water.
However, Datwyler Sealing Solutions does not test the lacquered aluminum for Bisphenol A on a
regular basis.
Considering the low level of extractable BPA and the fact that the lacquered flip caps, as secondary
packaging, have no direct contact to the product inside the sealed vial, the risk for migration of BPA
into the bottled drug is deemed very unlikely.
4.7 BSE/TSE
The Polypropylene (PP) plastic used for the production of flip caps may be produced with additives
that derive from tallow. The tallow derived raw materials used in the PP fulfill the requirements laid
down in the Note for Guidance, EMEA/410/01, rev. 3, part 6.4 (Tallow Derivatives). Our supplier
declares that the tallow derivatives are Category 3 materials and are manufactured under the
conditions given in the aforementioned Note for Guidance.
4.8 ICH Q3D Guideline

The ‘Step 4 ICH Q3D’ or ‘ICH Q3D’ guideline is a guideline that rules the presence of certain
elemental impurities in drug products. The permitted daily exposure of patients to defined elemental
impurities must be below a certain threshold that is specific for each element and depends on the
route of administration.
Elemental Impurities is more or less the same as what was formerly called ‘heavy metals’.
Q3D is a ruling for drug products. Primary packaging components of course can contribute to the
Elemental Impurities level in drugs if the leach such impurities.
Such leaching cannot come from secondary packaging components like flip caps since they are not in
direct contact with the drug. Therefore ICH Q3D is not applicable to flip caps.

4.9 Pork and Alcohol
Datwyler Sealing Solutions hereby declares that no product derived from pork are intentionally added
to the produced aluminum/plastic flip caps. We also state, that no drinkable alcohol is used for the
manufacturing of aluminum/plastic flip caps. However, isopropanol (IPA) is used in production for the
cleaning of production equipment.
Denatured alcohol (ethanol) may be used for certain tests on the products. However, these tests
typically do not get in contact with the products sent to customers.
4.10 Phthalates
Phthalates are substances added to certain plastics, typically PVC, to increase their flexibility,
transparency, durability, and longevity.
Neither the polypropylene nor the lacquer composition on the aluminum has phthalates intentionally
added. However, the presence of traces of these substances, in the amount of ppm, deriving from raw
material impurities, manufacturing equipment, processes or as omnipresent contaminations, can’t be
completely excluded.
4.11 Nonylphenol ethoxylates (NPE)

Nonylphenols are used in the manufacturing of antioxidants, lubricating oil additives, laundry and
dish detergents, emulsifiers, and solubilizers. Nonylphenol has attracted attention due to its
prevalence in the environment and its potential role as an endocrine disruptor and xenoestrogen, due
to its ability to act with estrogen-like activity.
Datwyler Pharma Packaging does not intentionally use or add Nonylphenols or any of its derivatives in
the production of flip caps. However, the presence of negligibly traces due to, among other things,
impurities in the products supplied by external parties, cannot be completely excluded. The absence
has not been checked by tests.
4.12 Octylphenol etoxylates (OPE)

OPE is a commonly used detergent in laboratories but it can also be an Ingredient in e.g. influenza
vaccines .
Datwyler Pharma Packaging does not intentionally use or add Octylphenol or any of its derivatives in
the production of flip caps. However, the presence of negligibly traces due to, among other things,
impurities in the products supplied by external parties, cannot be completely excluded. The absence
has not been checked by tests.

4.13 Asbestos
Asbestos is a naturally occurring silicate mineral. The prolonged inhalation of asbestos fibers can
cause serious illnesses including malignant lung cancer, mesothelioma, and asbestosis.
Datwyler Sealing Solutions does not use asbestos in the production of flip caps nor are asbestos
containing raw materials used in the flip cap production.
4.14 Calcium
During the production of aluminum caps or flip caps no calcium is intentionally added to the products.
However, it cannot be completely excluded that traces of calcium enter the product during the
production process of the used raw materials.
4.15 Chlorine
Chlorine in plastics is mainly found in PVC. However, no PVC or other chlorine containing substances
are being used for the manufacturing of flip caps at Datwyler Pharma Packaging. The absence has not
been checked by tests.
4.16 Polychlorinated and Polybrominated Diphenyl

Datwyler Pharma Packaging does not intentionally use or add polychlorinated and polybrominated
diphenyl or any of its derivatives in the production of flip caps. However, the presence of negligibly
traces due to, among other things, impurities in the products supplied by external parties, cannot be
completely excluded. The absence has not been checked by tests.
4.17 Conflict minerals

Conflict minerals are minerals mined in conditions of armed conflict and human rights abuses. These
minerals typically include columbite-tantalite, gold, wolframite, derivative of tantalum, tin, and tungsten.
No conflict minerals are intentionally added during the production of flip caps. Datwyler Sealing
Solutions is not aware of conflict minerals being used in the manufacturing of the raw materials used
for the manufacturing of flip caps.
4.18 Latex, gluten and lactose

Latex, gluten and lactose may cause allergic reactions for certain humans.
Datwyler Sealing Solutions does not use latex, gluten or lactose for the production of flip caps.
However, the presence of one or more of the above substances in the production area cannot be
completely excluded (gloves, etc.).

4.19 Allergens and other substances
We hereby confirm that the Datwyler Pharma Packaging does not add any of the following substances
to any of the manufactured products during the production process:
Animal by-products Nuts

Egg / protein Soy
Nickel Zinc
Fish / Shellfish Corn starch
Metabisulphite Galactomannan antigen
4.20 Nickel
The major source of nickel exposure is oral consumption, as nickel is essential to plants. Nickel is
found naturally in both food and water. The average daily exposure does not pose a threat to human
health. Most of the nickel absorbed every day by humans is removed by the kidneys and passed out of
the body through urine or is eliminated through the gastrointestinal tract without being absorbed.
Nickel is not a cumulative poison, but larger doses or chronic inhalation exposure may be toxic,
even carcinogenic, and constitute an occupational hazard.
Datwyler Pharma Packaging does not intentionally use or add Nickel in the production of flip caps.
However, the presence of traces in the products supplied by external parties, cannot be excluded. The
absence has not been checked by tests.

Sterilization
5.1 Steam sterilization
The materials used for the manufacturing of flip caps are resistant to terminal sterilization at 121°C for
30 minutes. To prevent premature opening of the flip caps during a terminal steam sterilization
process sufficient counter pressure needs to be used in the autoclave according to the filling level of
the vial.
5.2 Radiation sterilization

Datwyler Sealing Solutions offers Ready To Use (RTU) flip caps that are gamma sterilized according
to a validated process. It is not recommended to irradiate standard, non-RTU, flip caps by gamma or
beta sterilization.
Packaging
The packaging specification varies depending on product and customer specification.
Shelf life of flip caps

The recommended shelf life for non-irradiated flip caps, including RTU caps, before use
(capping) is 2 years. After capping the additional recommended shelf life is 5 years. This
shelf life is valid only for caps that were stored at ambient temperatures at all times.
This recommendation is based on testing 7 year old RTU caps.
This recommendation is specifically not valid for irradiated flip caps that were not
manufactures with the Datwyler RTU specification. RTU caps are manufactured with special
materials that were validated for the irradiation dose needed for RTU products. These
materials and conditions are not guaranteed for non-RTU caps.
Datwyler Quality level: Alu cap and Flip cap

The standard sampling plan and AQL’s for the Quality Level applied to all alu cap and flip cap product
for pharmaceutical applications are decribed below.
8.1 Sampling plan

The QC sample for finished product inspection is collected before final packaging of the finish goods
and it is representative of the full batch.
The inspection is performed in circumstances allowing the assessment of the inspected properties in
the state “as delivered”.
The sample size of the final inspection sample at Datwyler Pharma Packaging is based on the
sampling scheme conform ISO 2859 -1General inspection level I.

8.2 Defect classification
All defects observed during visual inspection are classified in 4 groups:
8.2.1 Critical defects:

- can endanger human life and health or
- violates legal requirements or
- seriously impairs the reliability of production tools, filling and packing equipment.
The presence of critical defects, or of products exhibiting critical defects, in deliveries of aluminum
products is « intolerable ».
8.2.2 Major A defects

- leads to insufficient function,
- leads to reduced production efficiency or
- impairs the reliability of production tools, filling and packaging equipment.
The presence of Major A defects in delivered aluminum products is prevented to the extent of the
technical possibilities, but deemed tolerable up to an AQL level as described in below table.
8.2.3 Major B defects have a limited risk of:

- leading to insufficient function
- leading to reduced production efficiency or
- impairing the reliability of production tools, filling and packaging equipment.
The presence of Major B defects in delivered aluminum products is prevented to the extent of the
technical possibilities, but deemed tolerable up to an AQL level as described in below table.
8.2.4 Minor defects

Minor defects present a departure from perfection with no consequences for the applicability of the
product bearing such a defect, often referred to as cosmetic defects on the outside/visible side of the
caps. The presence of minor defects in delivered aluminum products is prevented to the extent of the
technical and economical possibilities, but deemed tolerable up to an AQL level as described in below
table.

8.3 Specifications visual inspection
DEFECT CLASSIFICATION AQL SPECIFICATIONS
CRITICAL DEFECTS (CR)
Cross contamination or mix up Zero defects
Hairs and other biological contamination like insects 0.01
MAJOR A DEFECTS (MA)
Breaking lips/scoreline/bridges (with an impact on the opening
force)
Welding defect (with an impact on the opening force)
0.25
Deformation aluminum > 1mm²
Plastic disc not completely filled
Aluminum-cap not complete
MAJOR B DEFECTS (MB)
Debris, swarfs
Contamination > 1 mm² (e.g. oil, grease, dirt)
Burnings or dark particle on plastic disk > 1mm² 0.65
Color aluminum not in range
Color plastic disc not in range
Flashes (overflow) on plastic disc > 0,5mm
MINOR DEFECTS (m)
Air inclusions in plastic
Printing / stamping problem
Aluminum glitter / dust
Contamination < 1 mm² (e.g. oil, grease, dirt)
Burnings, dark particle on plastic disc < 1 mm²
Injection molding strings
Stains, spots, black lines on aluminum
Welding defect (without an impact on the opening force)
2.5
Deformation aluminum < 1 mm²
Wrinkles
Scratches / Lacquer defect on aluminum (without an impact on the
sterilization resistance)
Flashes on plastic disc < 0.5 mm²
Sink mark on plastic disc
Foreign color in plastic disc
Shadow on plastic disc

Scratches on plastic disc
Table 7: Specifications visual inspection

History
Edition Change Comment
(issue date) (chapter + change) (rationale)
1 (June 28, 2013) N/A First edition
2 (November 21, 2014) Added disclaimer regarding document Addition
distribution on front page
1 - Added Scope Addition
2.1 – Added UTO in properties Addition
2.2 – Description of FC added Addition
2.3 – Description of SFC added Addition
Difference between FC and SFC deleted Replaced by 2.2 and
2.3
2.4 – Description of UTO added Addition
General caution
2.9 - 3rd bullet point : reformulated text
statement
5.1 – Shelf life changed from 3+4 to 2+5 2.9 – Aligned with rubber
3 (November 27, 2019) 1 - Added FBC Addition

Chapter numbering corrected starting with table Likely incompatibility
of contents with older Word
version
3.4 – Added FBC section. All other chapters in Merging with
3 were pushed one number down CS0398-01
3.4.1 – Added chapter Merging with
CS0398-01
3.7 – Added section for FBC specific opening Merging with
forces CS0398-01
3.9 – Added reference to CS0374-01 for Addition
camera capabilities
3.11 – Added printing capability at Datwyler Addition
4.8 – Chapter added about ICH Q3D Guideline Addition
4.9 – Pork and Alcohol chapter added Addition
4.11 – Added nonylphenol ethoxylates chapter Addition
4.12 – Added octylphenol etoxylates chapter Addition
4.19 – Allergens chapter added Addition

4.20 – Nickel chapter added Addition
7 – RTU caps added to 2+5 shelf life, chapter Addition
renumbered to Heading 1
7.2 – Chapter removed Content added to 7
8 – Entire Chapter replaced with the same Replacement with

chapter from CS0398-01 up to date
information


CS - Flipcaps CS0270-01

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Approval Date : 28.11.

General Flip Cap Documentation

SFC Scoreline Flip Cap

FBC Flip Bridge Cap

UTO Universal Tear-Off

Table 1: Caps covered in this document

CS0270-01, Edition 1.0: General Flip Cap Documentation

CS0270-01, Edition 1.0: General Flip Cap Documentation

3.1 Functionality description

CS0270-01, Edition 1.0: General Flip Cap Documentation

3.3 Score-line Flip Caps (SFC)

Figure 2: Score-line flip caps

CS0270-01, Edition 1.0: General Flip Cap Documentation

13mm (long) Flip-Bridge Cap

Table 2: Specification for 13mm long FBC

13mm (standard) Flip-Bridge Cap

20mm Flip-Bridge Cap

CS0270-01, Edition 1.0: General Flip Cap Documentation

Figure 3: 13mm Flip Bridge cap (bottom view)

CS0270-01, Edition 1.0: General Flip Cap Documentation

Figure 3: 20mm Flip Bridge cap (top view)

CS0270-01, Edition 1.0: General Flip Cap Documentation

3.4.1 Cap design analysis and machinability trials

CS0270-01, Edition 1.0: General Flip Cap Documentation

CS0270-01, Edition 1.0: General Flip Cap Documentation

The opening mechanism of the UTO cap is shown in Figure 5

Figure 4: UTO cap after plastic disc removal

Figure 5: Usage of 3 piece UTO cap

3.6 Difference between standard and flush design flip caps

CS0270-01, Edition 1.0: General Flip Cap Documentation

Figure 6: Flush design flip caps

3.7 Opening forces

Cap diameter in Maximum opening force

CS0270-01, Edition 1.0: General Flip Cap Documentation

Example of Datwyler product code for Flip Caps:

SFC20.0001 001000 6002

3.9 Flip Cap production conditions

CS0270-01, Edition 1.0: General Flip Cap Documentation

The effects of these factors may be minimized by proper storage conditions.

Storage times should be minimized, first-in/first-out usage of stocks is highly recommended.

3.11 Printing on flip caps

CS0270-01, Edition 1.0: General Flip Cap Documentation

4.2 Epoxy lacquer

 Europe: 2007/19/CE, 2023/2006/CE

4.3 Polypropylene (PP)

CS0270-01, Edition 1.0: General Flip Cap Documentation

4.6 Bisphenol A (BPA)

4.8 ICH Q3D Guideline

CS0270-01, Edition 1.0: General Flip Cap Documentation

4.11 Nonylphenol ethoxylates (NPE)

4.12 Octylphenol etoxylates (OPE)

CS0270-01, Edition 1.0: General Flip Cap Documentation

4.16 Polychlorinated and Polybrominated Diphenyl

4.17 Conflict minerals

4.18 Latex, gluten and lactose

CS0270-01, Edition 1.0: General Flip Cap Documentation

Animal by-products Nuts

CS0270-01, Edition 1.0: General Flip Cap Documentation

5.2 Radiation sterilization

Shelf life of flip caps

Datwyler Quality level: Alu cap and Flip cap

8.1 Sampling plan

CS0270-01, Edition 1.0: General Flip Cap Documentation