Oxygen absorbers
for pharmaceuticals

Oxygen absorber for liquid pharmaceuticals
Oxygen absorber for solid pharmaceuticals

Oxygen absorber with drying function forsolid pharmaceuticals and medical devices

AGELESS OMAC
TM

Oxygen-absorbing ﬁlm

High gas-barrier bottle

MoistureVanishTM
AGELESS EYEOxygen indicatorLineup of oxygen absorbers for pharmaceuticals
We provide a wide variety of products to maintain the quality ofpharmaceuticals and medical devices.
High moisture Reference examples of pharmaceuticals and medical devices which the products are applied to Low moisture

Eye drop

Preﬁlled syringe

Oxygen absorber for liquid pharmaceuticals

Dialyzer

Solid pharmaceuticals

Inhaler

Stent

Oxygen absorber for solid pharmaceuticals
with medium moisture content

CatheterSolidpharmaceuticals

API

Oxygen absorber for solid pharmaceuticals withlow moisture content and medical devices

FX-PAN

SS-MBC

ZM

ZM-C

KD

CD

page 3.

page 3.

page 5.

page 5.

page 7.

page 7.

Liquid pharmaceuticals- Infusion bags
- Injections- Compliance with FDA- Registered in DMF- Heat resistant- Compliance with FDA- Registered in DMF

0.65〜0.95

Within 20 hours（25±2℃/100%RH）

Within 24 hours（25±2℃/40〜60%RH）

AGELESS EYE- Compliance with FDA- Registered in DMF- Canister type
- Compliance with FDA- In preparation forregistration for DMF

Solid pharmaceuticals
Medical devices- Compliance with FDA- Registered in DMF- Canister type
- Compliance with FDA- Registered in DMF

0.3〜0.65

0.3 or lessWithin 30 days
（25±2℃/40〜60%RH）

Within 7 days
（25℃）

AGELESS OMACHigh gas-barrier bottle

OMAC

OXB

page 9.

page 4.

page 6.

Liquid pharmaceuticals- Infusion bags
- Injections

Liquid pharmaceuticals- Infusion bags
- Eye drops

Solid pharmaceuticals
Supplements

Tablet type

- Oxygen absorbing function- Compliance with FDA- Registered in DMF- Oxygen Barrier bottle- Compliance with FDA- In preparation for registration for DMF

Range to be applied (Aw)
0.10〜0.99（5〜35℃）

Oxygen absorption capacity
0.1〜0.5ml/cm²

Appearance

Type

EYE- LS

Main
application

Oxygen-absorbing ﬁlm

TMFeatureOxygen indicator

Solid pharmaceuticals
Medical devices
Supplements

Note

Variety

Oxygenabsorption
time

Range to be
applied (Activity ofwater/Aw)

FeatureMainapplication

Appearance

Type

Variety

Infusion bag

1

Oxygen permeability
0.5ml/m²・atm・24h※25℃/40〜60%RH

Water vapor
permeabizlity
0.1g/m²・24h※25℃/100%RH
With 10g silica gel

Eﬀects of deoxygenated packages
1

Stability of API azelnidipine
1.40

Analog (mol%)

1.20
1.00
0.80
0.60

Control group

0.40

Oxygen absorbing package
Oxygen and moisture absorbing package

0.20
0.00

Moisture absorbing package
0

1

2

3

Conditions: 25 ºC, 60% RH

4

5

Storage period (month)67○ The APT, azelnidipine, became stable by use of an oxygen and moistureabsorbing package
Retention of lactic acid bacteria count■ Initial property■ Storage test

No

Lactic acid bacteria count (cfu/g)

1

2.3×10⁹2

2.7×10⁹3

2.9×10⁹

Lactic acid bacteria count (cfu/g)2

1.0×10¹⁰
1.0×10⁹
1.0×10⁸
1.0×10⁷
1.0×10⁶
1.0×10⁵
1.0×10⁴

Oxygen absorbing package

1.0×10³

Oxygen and moistureabsorbing package

1.0×10²

Moisture absorbing package

1.0×10¹
1.0×10⁰

Control group
0

30

60

Storage period (day)Conditions: Under normal temperature (25 ºC)

90○ Effect to maintain the lactic acid bacteria count was confirmed in useof an oxygen and moisture absorbing package.
3

Antioxidative eﬀect [DHA, EPA supplement]

Oxygen absorbing
package

Control group

3 months

6 months

9 months

12 months

O₂

0.01% or less

0.01% or less

0.01% or less

0.01% or less
0.1% or less

CO₂

0.1% or less

0.1% or less

0.1% or less

Smell

○

○

○

○

POV (meq/kg)

2.4

2

1.9

1.8
0.1 or less

AV (KOHmg/g)

0.1 or less

0.1 or less

0.1 or less

Vitamin E (mg/100 g)

15.8

15.4

15.3

15.9

O₂

20.28

19.38

19.03

20.75

CO₂

0.1

0.1

0.1

0.1

Smell

＋〜＋＋

＋＋

＋＋＋

＋＋＋

POV (meq/kg)

5.8

8.6

10.1

15

AV (KOHmg/g)

0.1

0.1

0.1

0.1

Vitamin E (mg/100 g)

15.5

14.5

13.7

12.9

Note 1): Smell: ○: Normal, + ~ +++: Slightly ~ highly abnormal
Storage test: 35 ºC○ Oxidation of fats and oils and occurrence of an abnormal smell were prevented.
2

Oxygen absorber for liquid pharmaceuticals
Product

Appearance

Type

Main application

Oxygen absorption time

Within 20 hours（25±2℃/１０0%RH）

FX-PAN

Liquid pharmaceuticals- Infusion bags
- Injections
Within 24 hours（25±2℃/40〜60%RH）

SS-MBC

FeatureQuantity

Product
No

Oxygenabsorption
capacity (mL)Size (mm)FX-50PAN

50

40×37

6,000(500×12)-

FX-PAN FX-100PAN

100

50×41

3,000(300×10)-

FX-200PAN

200

50×52

1,500(300×5)-

SS-100MBC

100

45×40

3,000(100×30)

3,000(1,500×2)

SS-200MBC

200

45×55

2,000(100×20)

2,000(2,000×1)

Type

Handling time

Loose (packets in a bag × bags) Roll (packets in a roll × rolls)

SS-MBC SS-300MBC

300

60×65

1,500(100×15)-

SS-400MBC

400

60×70

1,000(100×10)-

SS-500MBC

500

65×75

1,000(100×20)

1,000(500×2)

Within 8 hours(25℃/under 70%RH)
Within 4 hours(25℃/70%˜90%RH)
Loose types :Within 2hrs for
Products with Aw 0.65-0.95
Roll types:
1,000 or more sachets per hour

○ Prevents oxygen-caused deterioration in the quality of liquid pharmaceuticals,even when resin containers are used.

○ Keeps the quality from deteriorating due to slight oxygen entering from theouter container, which cannot be fully removed in a package with an inert gas,such as nitrogen (the oxygen concentration within a container is maintained
at 0.1% or less).

○ Absorbs dissolved oxygen from a drug solution.
Point

Storage method and guarantee period (unopened outer package only)* Store the unopened carton box at room temperature (at or below 30 ºC even in summer)away from direct sunlight.
* The guarantee period is 12 months after shipment.

NoticeWhen wrongly used, AGELESS absorbs oxygen in air before packaging andfails to produce the expected eﬀects.

Don t

Used AGELESS cannot be reused because the eﬀectiveness may be lost.
3

AGELESS OMAC Oxygen-absorbing ﬁlm for liquid pharmaceuticals
Product

Type

Appearance

OMAC

Film structure

Main application

Oxygen absorption capacity

Liquid pharmaceuticals- Infusion bags
- Eye drops

0.1〜0.5ml/cm²

Type

Thickness of ﬁlm (μ)

Handling time

Guarantee period

OMAC

90〜130μ

Within 24 hours after the outer
package is opened.
(23 ºC / 60% RH)

6 months after production○ AGELESS OMAC film has a special structure composed of four layers.
Oxygen outside of the package

Outer layer: PET, nylon, etc.
Barrier layer: Aluminum foil, MXD6, EVOH, inorganic evaporated ﬁlm, etc.
Oxygen absorbing layer: Polyoleﬁn (PP or PE) + iron based oxygen absorbing agent
Sealant layer: Polyoleﬁn (PP or PE)
Oxygen inside of the package○ Absorbs oxygen from a container.
○ Removes dissolved oxygen from the contents of a container.
○ Saves the time and eﬀort of inserting oxygen absorbers.
○ Available as bag and roll products.
■ For heat application■ For non-heat application

Dissolved oxygen
concentration (ppm)

Head space oxygen
concentration (%)
25

10

1

0.1

20

Before retort
processing

15

After retort
processing

1050
Before retort
processing

After retort
processing

Day 1 ofstorage

Day 2 ofstorage

Conditions: 121 ºC for 30 min, Water 200 mL, Air 5 mL
4Oxygen concentration (%)

FeatureInitial oxygen
concentration 20.5%
Initial oxygen
concentration 0.5%

100

10

1

0.1

0.01

0

1

2

3

4

5

Elapsed time (day)6

7

Figure: Oxygen absorbing speed under the conditionof non-heating of PE-based OMAC (25 ºC)
Film size: 264 cm2 (110 × 120 mm, both sides)
Air volume of 40 cc, 90% RH, 25 ºC* The above data are our measurements and not guaranteed.

Oxygen absorber for solid pharmaceuticals with medium moisture content
Product

Type

Appearance

Main application

Oxygenabsorption time

FeatureZM-1
Compliancewith FDA
Registeredin DMF

Solid pharmaceuticals
with medium moisture
content
Medical devices
Supplements

ZM-1R

Within 30 days
（25±2℃/40〜60%RH）

ZM-1C（Development
product）

Type

ZM

FeatureCanister type

Loose
Roll
(packets in a bag × bags) (packets in a roll ×rolls)

Handling time

40×20

8,000(200×40)-

Within 4 hours

100

40×20

-

8,000(4,000×2)

1,000 or moresachets per hour

10014.0φ×18

8,000(800×10)-

Within 4 hours

Product No.

Oxygen absorption
capacity (mL)Size (mm)

ZM-1

100

ZM-1R
ZM-1C

○ Prevents oxygen-caused deterioration in the quality of sold pharmaceuticals and also prevents
moisture from transferring from the inside of the oxygen absorber to the sold pharmaceutical.
○ Has high oxygen absorbing ability in the small sachet.

Oxygen concentration (%)■ Oxygen absorbing speed
20

100
90
80

15

Temperature(ºC)

70

Humidity (% RH)

60
10

50
40
30

5

20
10

0

0

10

Conditions: 25 ºC, Air volume 40 mL

Point■ Change in humidity inside the container

20

30

40

0

50

Oxygen absorption time (h)

0

10

20

30

Conditions: 25 ºC, 55% RH

40

50

60

70

80

90

100

Elapsed time (h)Storage method and guarantee period (unopened outer package only)* Store the unopened carton box at room temperature (at or below 30 ºC even in summer) away from direct sunlight.
* The quality guarantee period is 12 months after shipment.
5

High gas-barrier bottle

TM

Product

Type

Appearance

Main application

Performance

Solid pharmaceuticals
Supplement

OXB

Oxygen permeability
0.5ml/m²・atm・24h※25℃/40〜60%RH

Water vapor
permeability
0.1g/m²・24h※25℃/100%RH
With 10 g silica gel

Product No.

Capacity (mL)

Total capacity(O. F. mL)

Bore (mm)Size (Bottle body diameter(Φmm) × total height (mm))

Quantity

OXB-40

40

51.0

25.3

38.1×60.6

430

OXB-60

60

73.5

25.3

39.8×74.4

320

OXB-100

100

116.5

25.3

48.5×85.2

200

OxyBarrier™ is not included in our quality management system, ISO 9001.

Bottle structure〇 OxyBarrier™ has a special structure composed of five layers (three types).
O₂

O₂

O₂
Outer layer
Adhesion layer

Barrier layer: Oxygen permeation is prevented.
Adhesion layer
Inner layer

Feature○ Prevents oxygen, which will cause pharmaceutical deterioration, fromentering from the outside.
○ Maintains the oxygen concentration in a bottle at a low level by a combinationof an oxygen absorber for long-term storage of pharmaceuticals.
○ Needs only a small oxygen absorber because of its high barrier properties.
■ Oxygen permeability ml/m²・atm・24h

OxyBarrier™

Non-barrier bottle
by a competitor

Oxygen permeability
mL/m2 • atm • 24 h

0.5

129

Oxygen permeability of
100 mL bottle (mL/year)

2.5

645

OxyBarrier™

Non-barrier bottle
by a competitor

Water vapor permeability
g/m2 • 24 h

0.1

0.13

Moisture permeability of
100 mL bottle (g/year)

0.5

0.65

140
120
100
80

* Study conditions: 25 ºC. 40-60% RH

60
40
20
0

OxyBarrier™

Non-barrier bottle
by a competitor* Study conditions: 10 g silica gel was put in a bottle and the sealed bottle was stored at 25 ºC and 100% RH for 28 days.

6For consideration of1

Out-gases
PharmaKeep generates a little amount of out-gases. It is diﬃcult for us to conﬁrm every
eﬀect of out-gases to each customer s products. We would like to ask our customers to
conﬁrm eﬀects of PharmaKeep by tests with actual products at actual conditions.
Table 1: Out-gases from PharmaKeep PACKET KD-20 after oxygen absorption *1

Out gases

Gas concentration(per 1 piece/500 ml air)Out gases

Gas concentration(per 1 piece/500ml air)Carbon dioxide

0.44% *2

Acetaldehyde

1ppm *3

Carbon monoxide

N.D. *2

Methane13ppm *4

Hydrogen

0.05% *2

Ethane10ppm *4

Formaldehyde

1.5ppm *3

Propane1ppm *4*1) Typical analytical data of PharmaKeep packet KD-20 (Lot. No.3121ES). This data is not guaranteed value.
*2) Analyzed by GC-TCD / One piece of KD-20 with 500 ml of air for 14 days at 25 ˚C.
*3) Analyzed by gas detector tube system(GASTEC) / Three pieces of KD-20 with 1,500 ml of air for 14 days at 25 ˚C.
*4) Analyzed by GC-FID / One piece of KD-20 with 500 ml of air for 14 days at 25 ˚C.

2

Smell
PharmaKeep products may generate smell by oxygen absorption. We recommendthat customers conﬁrm eﬀects of PharmaKeep by tests with their products.

3

Adhesion of granules
Small amount of PharmaKeep granules may adhere to surface of PharmaKeep sachetsand canisters. We recommend that customers conﬁrm eﬀects of PharmaKeep by tests
with their products.

4

Test of ﬁnal packaging of products with PharmaKeep
During customers tests with PharmaKeep should be considered packaging headspace,packaging permeation, possible leakages at the packaging closure, but also possible
presence of defects in the drug packaging itself. In case of none estimated leakages,
and / or undetected packaging defects, preserved medicine might be oxidized despiteof PharmaKeep presence.
8

MoistureVanishTM Bottle with moisture absorbing function
Product

Type

Appearance

MVC

Main application

Moisture absorption capacity (g)Solidpharmaceuticals

0.4(40℃/90%RH)

Type

Capacity (mL)

Total capacity (O.F.mL)

Bore (mm)Size (Bottle body diameter(Φ mm) × total height (mm))

Quantity

MVC-100

100

116.5

25.3

48.5×85.2

200

MoistureVanish™ is not included in our quality management system, ISO 9001.

Bottle structure〇 Moisture Vanish™ has a special structure composed of three layer.
H₂O

H₂O

H₂O

Out layer : Moisture permission is prevented.

Moisture absorption layer
H₂O

FeatureH₂O

Inner layer

H₂O○ The moisture absorption function saves the time and eﬀort of inserting desiccants.
○ Maintains low humidity in the bottle to prevent hydrolysis of the API.

OXB ClosureTM OxyBarrier s cap
Product○ The induction seal (high-frequency aluminum foil seal) put on the mouth of
OxyBarrier prevents oxygen from entering from the ﬁt between the bottle and the cap.

Type

FeatureQuantity

CL-32ST

Packing with induction seal

2,000
OXB Closure™ is not included in our quality management system, ISO 9001.

9

Oxygen absorber for liquid pharmaceuticals(General type)

Product

Type

Appearance

ZPT-MBCType

ZPT-MBC

Main application

Oxygen absorption time

Liquid pharmaceuticals- Syringe- Ampule- API (Large type)

Within 2 days
(Within 6 days for lager
products than ZPT-500MBC)

Product No.

Oxygenabsorption
capacity
(mL)

Size
(mm)

ZPT-20MBC

20

ZPT-30MBC

Quantity
Loose(packets in a
bag × bags)

Roll(packets ina roll ×rolls)

40×30

12,000（400×30）

-

30

40×35

8,000（200×40） 8,000（4,000×2）

ZPT-50MBC

50

40×40

6,000（200×20） 6,000（3,000×2）

ZPT-100MBC

100

45×40

3,000（100×30） 3,000（1,500×2）

ZPT-200MBC

200

45×55

1,500（100×15） 1,500（750×2）

ZPT-300MBC

300

60×60

1,500（100×15） 1,500（750×2）

ZPT-500MBC

500

60×70

1,000（100×10） 1,000（500×2）

ZPT-1000MBC

1,000

100×65500（50×10）-

ZPT-2000MBC

2,000

100×90250（25×10）-

ZPT-3000MBC

3,000

100×105200（20×10）-

Handling time
(water activity value of
product to be applied)

Loose: Within 4 hours
Roll:·1,000 or more sachets
per hour(ZPT-20MBC to
ZPT-300MBC)·500 or more sachets
per hour(ZPT-500MBC)

Feature○ Prevents oxygen-caused deterioration in the quality of liquid pharmaceuticals, even when resin
containers are used.
○ Keeps the quality from deteriorating due to slight oxygen entering from the outer container,
which cannot be fully removed in a package with an inert gas, such as nitrogen (the oxygen
concentration within a container is maintained at 0.1% or less).
○ Absorbs dissolved oxygen from a drug solution.

Point

AGELESS storage method and guarantee period (unopened outer package only)* Store the unopened carton box at room temperature (at or below 30 ºC even in summer) away from direct sunlight.
* The guarantee period is 6 or 12 months after shipment.

NoticeWhen wrongly used, AGELESS absorbs oxygen in air before packaging and fails to produce the expected eﬀects.

Don t

Used AGELESS cannot be reused because the eﬀectiveness may be lost.
10

AGELESS-EYE Oxygen indicator
Product

Type

Appearance

EYE-LSType

Size

Quantity

Conditions of use

Tablet type

41×33(mm)6,000(500 packets
× 12 bags)

5〜35℃、
Aw0.10〜0.99

Not Compliance with FDA

Feature○ Allows to visually check the oxygen-free state (oxygen concentration:
0.1% or less) in a container or a package by color-changing.
■ Image of color changing
Oxygen-free state (0.1% or less)

Oxygen: 0.5% or moreIn this interval, the color steplessly
changes between pink and blue
depending on oxygen concentrations.

* Blue to pink: 2-3 hours after the oxygen-free state is achieved (25 ºC)* Pink to blue: Several minutes after contacting with oxygen (25 ºC)■ Storage method and guarantee period of AGELESS EYEAGELESS-EYE products are delivered by room temperature courier service, and on arrival,
immediately place them in a refrigerator and keep them at or below 15 ºC with protection from light.
AGELESS-EYE

Guarantee period

Tablet type

6 months after shipment, 15 ºC

The oxygen concentration and time required for discoloration are rough tandards and not guaranteed.
Discoloration occurs more slowly at lower temperatures.

■ How to use AGELESS-EYE- Take out a required quantity from the outer bag.
- Enclose an AGELESS-EYE together with an oxygen absorber in a package of the product.
- Apply AGELESS-EYE to the products within 12 hours (operation time). Apply AGELESS-EYE under the operation
environment avoiding direct sunlight and a particularly strong light (brightness: 500 lux or below).
- Performance of AGELESS-EYE® decreases when it is left in air for a long time, exposed to light for a long time,and stored at high temperature (over room temperature).
- AGELESS-EYE cannot be recused because the discoloration performance gradually decreases.
- After unpackaging of the outer bag of AGELESS-EYE , enclose self-reacting AGELESS Z or S type (size: 100 orabove) in the bag, seal the bag to make it oxygen-free state with protection from light , and be sure to store it
in a refrigerator at or below 15 °C.
The pink tone of AGELESS-EYE® indicates that oxygen concentration inside of the container is 0.1% or less anddoes not directly indicate the packaging status or the quality of the product.
11

Handling of Oxygen absorbers
An oxygen absorber, combined with packaging materials with high gas barrier properties,
absorbs oxygen in a sealed container to maintain an oxygen-free condition (oxygen
concentration: 0.1% or less) for a certain period. Appropriate method of use and points inpackaging with oxygen absorbers are as follows.

Four conditions to achieve oxygen-free state
Condition 1

Prepare packaging materials with high gas barrier properties

Select materials with low oxygen permeability in order to keep the inside of thecontainer oxygen-free for a certain period.
In packaging with oxygen absorbers, materials with high gas barrier properties,
including resin bags and bottles, aluminum bags, and glass bottles, are used.
Condition 2

Select oxygen absorbers appropriate for properties of products and packaging containers

In order to keep the inside of the packaging container oxygen-free within thestorage period of the target products, select the type appropriate for propertiesof products and packaging containers and the size corresponding to the total of
the initial amount of oxygen in a packaging container and the amount of oxygen
permeating the packaging container within the storage period.
Condition 3

Ensure comeplete sealing using a sealer etc

If a package with an oxygen absorber is not completely sealed, it does not
become oxygen-free.
Completely seal the container with a sealer or another tool.
Condition 4

Appropriately handle oxygen absorbers

Misuse of oxygen absorbers results in loss of eﬀectiveness, etc.
Handling conditions of oxygen absorbers depend on their types. Promptly andappropriately open, use, and store them according to the speciﬁed conditions.
Once the package is opened, take out and discard the oxygen absorber.

Conﬁrmation by implementation testing of product
Before application of oxygen absorbers, perform implementation test using the ﬁnished products to
conﬁrm the eﬀects of oxygen absorbers. If the oxygen-free condition is not maintained because of
packages, etc. of the ﬁnished products with a pinhole made during the distribution process, thepharmaceuticals may be deteriorated by oxidation. In such case, verify whether the pharmaceuticals
have negative eﬀects on the human body and then take measures, as appropriate.
○ Generally, it is necessary to select materials with low oxygen permeability in order to keep the inside of the container
oxygen-free for a certain period.
* Make sure to perform implementation test to conﬁrm the adequacy o f the packaging materials.
○ Do not use blades, such as a cutter, to open the carton box.
○ The outer bag of packet products is vacuum packaged. Hang the outer bag from one end to conﬁrm that the content does not drop
to the other end. When the packets drop to the bottom, do not use them because the outer bag may have a pinhole. If the vacuumin an outer bag is lost when opening the carton box, contact our distributor to replace the outer bag.
12

Strength as a leading manufacturer in the oxygen absorber industry
1

Dependable business continuity planning (BCP)
Stable supply- Two main production sites located in Japan and Thailand- Product warehouses in several locations in Japan and abroad

2

Broad product lineup- Abundant product lineup available for drug dosage forms and their properties- Products complying with FDA/EU regulations; including products registeredin DMF

3

Experienced technical service- Data acquisition and troubleshooting in AGELESS Service Center

4

Thorough quality control- ISO 9001 certiﬁed- State-of-the-art equipment and the quality appreciated for many years

5

Achievements in the medical use over the years- Achievements in supplying the products to many domestic and overseas
pharmaceutical manufacturers- Caring customer service and innovative product development

13

Research and Development Center of
Oxygen Absorbers

Tokyo Techno Park (TTP),
Mitsubishi Gas Chemical Company, Inc.

Technical Service of
Oxygen Absorbers

AGELESS Service Center, Tokyo Oﬃce,
MGC AGELESS Company Limited

Production Plant of
Oxygen Absorbers

Shirakawa Oﬃce,
MGC AGELESS Company Limited

Production Plant of
Oxygen Absorbers

AGELESS (THAILAND) CO.,LTD.

14