PACKAGING SOLUTIONSFor Successful Products

ISSUE 13

Argonews

NOVEMBER 2016

CONTENTS

3ARGO AT CPHI 2016 IN BARCELONA

4 / 5PET JARS M38 - M43 / 60 ML PET BOTTLE / VAGINAL APPLICATORS

6 / 7PYCLEAR™ PROTECTION /

/5ML TE030 / DELTARHINO NASAL SPRAY

8 / 9DRUG MASTER FILE (DMF) / INTERNAL TRAINING/

/NEW ADDITIONS TO UN CERTIFIED ARGO BOTTLES

10 / 11NEW PET 3-5L CANISTERS / M-JARS FOR FERTILIZERS /

/THE PRINTING OF PLASTIC TUBES

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ARGO at CPhI in BarcelonaCPhI Worldwide 2016 took place in Barcelona this year, for a standard of 3 days, 4-6 of October. This was ARGO’s 4th consecutive participation to the exhibition, with a booth in the Innopack Hall that gives focus on pharmaceutical packaging and drug delivery systems. For most companies in the Pharma Industry these 3 days are an opportunity to meet one-to-one with hundreds of suppliers and customers, existing or prospective, discuss and filter the new market trends, services and products and interact with people from the segment to envisage new approaches and ideas.

This year, apart from the new additions in our product portfolio, we were happy to present during the event our mutual referencing agreement with Pylote Companyto offer unique innovative packaging solutions in the Pharma industry. Following a successful industrial evaluation, ARGO and Pylote have developed a new combined solution. Pylote brings its breakthrough innovation, PYCLEAR™ PROTECTION that protects patients from the risk of external microbial contamination, while allowing pharma companies to eliminate the use of preservatives, and ARGO brings its expertise in plastic packaging and eye dropper products.

PYCLEAR™ PROTECTION, following the winning for ‘Best Exhibitor Innovation’ Award in the ‘patient protection and cost-efficiency’ category in Pharmapack 2016, has received the Excellence in Pharma Packaging award at CPhI WorldWide 2016

More on the PYCLEAR™ PROTECTION technology

on page 6 ➔

STAND 2K36

2016

ARGO is always striving to keep up with market trends.We have developed for the food supplement market the range of PET jars for pills with capacities of 100ml and 150ml. Following the first production of the PET jars for pills paired with 38mm cap with induction sealing liner at the end of last year, this year we expanded our pro-duct portfolio with PET jars matched with ARGO’s 43mm Snap-On Mirage cap. Both jars and caps can be offered in a various range of colors to best serve our customers’ needs.Dacia Plant is one of the customers that use this range of products, produced at ARGO-ROM Plastics. Based in Brasov, Romania, Dacia Plant has managed in 14 years of activity to become one of the top five food supple-ment producers on the local market, with presence in major pharmacy chains, hypermarkets and health stores.

PET Jars M38 - M43

Mediphar Laboratories (Lebanon) has chosen ARGO’s standard PET 60ml bottle for its product Med - Erythromycin 4%. The bottle is white and decorated with silk screen printing. Med-Erythromycin 4% is an alcohol-based topical solution indicated for the treatment of «acne vulgaris», the most common acne type. Mediphar Laboratories has selected ARGO’s PET bottles 28PP for all their liquid form preparations, such as syrups and suspensions. ARGO’s PET 28PP series has standard neck dimensions in order to fit perfectly with various 28PP caps (plastic, aluminum, CR).

This year, Dacia Plant started a process of refreshing the image of its products on the market. One of the big changes was the switch from PE bottles to ARGO-ROM’s PET jars of 150ml for its main brands. The pro-ducts that belong to the core brand are packed in green jars and matched with green 43mm Mirage caps. For other ranges, the same jars and caps are used in differ-ent color combinations: white with matching caps, ma-genta with matching caps and blue with grey caps.

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Mediphar 60ml PET Bottlefor Mediphar Laboratories

The first model of the vaginal applicator M9 gives a dosage of 5 g ± 10%.

Akrikhin uses this vaginal applicator in single sleeve packaging for its products Clindacin® B prolong cream 2 % + 2 % and Clindacin® cream 2%.Akrikhin is today one of the 5 leading Russian pharmaceutical companies manufacturing more than 200 high quality medicinal products of the main pharmacotherapeutic fields, affordable and effective for the end user.

ARGO’s product range of vaginal applicators was recently enriched with two new products, which have the same shape as the “N” applicator, but a dosage of ½ and ¼ of the initial one. Hence, the full range of ARGO’s vaginal applicators consists of four different types for an M9 and one for an S13 tube thread. The option of applying a flow-pack solution, gives ARGO the opportunity to offer single packaging or sets of seven and nine pieces. Other packaging combinations, according to customers’ needs, can also be provided.Examples of use of ARGO’s vaginal applicators are featured through the products of the following companies:

Vaginal applicators

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Vaginal applicator “N” provides a full dosage of 5 g ± 10%.

Help Pharmaceuticals uses this vaginal applicator packed in sets of 7 pieces for its product Climycen® (Clindamycin) - Vaginal cream 2% (TUB x 40g +7 applicators). The Greek company Help Pharmaceuticals focuses on research, production and supply of high quality pharmaceutical products, with a Research & Development Lab continuously upgraded according to the European Standards.

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Breakthrough Innovation replaces antimicrobial preservatives

Only solution with complete statutory compliance

Pyrolyse pulvérisée®

Materials integration

Contamination protection

Improved ceramic microspheres obtained via one step «cleantech» manufacturing process: Pyrolyse pulvérisée®

Microspheres are integrated directly to final product materials by using the existing manufacturing process (like colorant in plastics transformation).

Existing Manufacturing Process

Tip contamination protection:Antimicrobial activity of material controlled using JIS Z 2801 standard for evaluation of antimicrobial surfaces

Dose and contents protection:Full protection controlled with severe in-use test based on deliberate contamination of tip and contents

Removes the use of preservatives

More eco-friendly products

• Tip contamination protection: Antimicrobial activity of material controlled using JIS Z 2801 standard for evaluation of antimicrobial surfaces

• Dose and contents protection: full protection controlled with severe in-use test based on deliberate contamination of tip and contents

CFU numerations/cm² after 0h (control) and 24h (Control and Assay) of contact – log reductions/cm²

(1) Br J Ophthalmol. 2007 Oct;91(10):1265-8. Epub 2007 May 2

(2) Accepted paper (2016): “Unpreserved opthalmic formula: PYCLEARTM PROTECTION fully controlled risk of contamination with common 3-parts eye droppers”.

(3) Submitted paper: “PYCLEARTM PROTECTION an innovative technology using new microspheres to avoid microbial contamination of multi-use ophthalmic solutions”.

Scientific research articles available: www.pylote.com/publications

• Pyrolyse Pulvérisée ® leads to controlled microspheres surface defects

• Interstitial ions and oxygen vacancies generate reactive species

• Reactive species presents very short life (ns), very short action distance (nm)

• Microspheres are never consumed, based on an action by direct contact

Context Pyrolyse pulvérisée ®

Mineral microspheres

Contamination protection

Mechanism(3)

Market Regulatory pressures: • Classic antimicrobial preservatives in Pharmaceutic formulations can have important side effects for patients

• In a worldwide trend, Health authorities encouraging use of unpreserved dispensers for opthalmic/nasal use

Materials Regulatory pressures:• Authorities recommend limiting the launch of products containing nanoparticles of silver

Contamination localization(1):

> 85 % located on tip

< 15 % located in residual solution

Only solution with complete statutory compliance

• Authorized by FDA / European Pharmacopoeia and Ecocert

• Realization of extraction measure according to Pharmacopoeia

• Eco-design, cleantech & cost-effi ciency approach

• Perfectly reliable product for patient

Removes the use of preservatives

• Protects against risk of external contamination and from risk of adverse effects of preservatives used in conventional 3-part eye dropper device

• Protects patients throughout the treatment period

• “Pylote added” products have advantage of removing risk of contamination of the Nozzle Tips

• Ensure clean & pure doses upon each application

• Provides protection with no change in patient treatment methods

More eco-friendly products

• Solution adaptable to every type of packaging and manufacturer

• Improvement in supply security as multi-dose packaging “Pylote added” can be multi-sourced

• Immediate gain (with no investment) with multi-sourced supply

• Highly suited for multi-dose eye drop fl asks, catheters and nasal

BREAKTHROUGH INNOVATION | REPLACES ANTIMICROBIAL PRESERVATIVES (2)

Improved ceramic microspheres obtained via one step « cleantech » manufacturing process : Pyrolyse pulvérisée®

1 to N compounds DRYING DECOMPOSITION DENSIFICATION

• Mineral microspheres at the heart of the « Pylote effect »

• Micron average size & narrow size distribution

Materials integration• Microspheres are integrated directly to final product materials by using the existing manufacturing process (like colorant in plastics transformation).

Strains C T0 C 24h A 24hLog

reduction per cm2

S. aureusCIP 53156

4.10 ± 0.09

3.56 ± 0.12

< 0.65 ± 1.12 > 2.9

E. coliCIP 53126

4.00 ± 0.03

4.17 ± 1.59

0.00 ± 0.00 > 4.2

EXISTING MANUFACTURING PROCESS

Contamination

Standard

Pylote Added

100%

0%

Weeks

• Tip contamination protection: Antimicrobial activity of material controlled using JIS Z 2801 standard for evaluation of antimicrobial surfaces

• Dose and contents protection: full protection controlled with severe in-use test based on deliberate contamination of tip and contents

CFU numerations/cm² after 0h (control) and 24h (Control and Assay) of contact – log reductions/cm²

(1) Br J Ophthalmol. 2007 Oct;91(10):1265-8. Epub 2007 May 2

(2) Accepted paper (2016): “Unpreserved opthalmic formula: PYCLEARTM PROTECTION fully controlled risk of contamination with common 3-parts eye droppers”.

(3) Submitted paper: “PYCLEARTM PROTECTION an innovative technology using new microspheres to avoid microbial contamination of multi-use ophthalmic solutions”.

Scientific research articles available: www.pylote.com/publications

• Pyrolyse Pulvérisée ® leads to controlled microspheres surface defects

• Interstitial ions and oxygen vacancies generate reactive species

• Reactive species presents very short life (ns), very short action distance (nm)

• Microspheres are never consumed, based on an action by direct contact

Context Pyrolyse pulvérisée ®

Mineral microspheres

Contamination protection

Mechanism(3)

Market Regulatory pressures: • Classic antimicrobial preservatives in Pharmaceutic formulations can have important side effects for patients

• In a worldwide trend, Health authorities encouraging use of unpreserved dispensers for opthalmic/nasal use

Materials Regulatory pressures:• Authorities recommend limiting the launch of products containing nanoparticles of silver

Contamination localization(1):

> 85 % located on tip

< 15 % located in residual solution

Only solution with complete statutory compliance

• Authorized by FDA / European Pharmacopoeia and Ecocert

• Realization of extraction measure according to Pharmacopoeia

• Eco-design, cleantech & cost-effi ciency approach

• Perfectly reliable product for patient

Removes the use of preservatives

• Protects against risk of external contamination and from risk of adverse effects of preservatives used in conventional 3-part eye dropper device

• Protects patients throughout the treatment period

• “Pylote added” products have advantage of removing risk of contamination of the Nozzle Tips

• Ensure clean & pure doses upon each application

• Provides protection with no change in patient treatment methods

More eco-friendly products

• Solution adaptable to every type of packaging and manufacturer

• Improvement in supply security as multi-dose packaging “Pylote added” can be multi-sourced

• Immediate gain (with no investment) with multi-sourced supply

• Highly suited for multi-dose eye drop fl asks, catheters and nasal

BREAKTHROUGH INNOVATION | REPLACES ANTIMICROBIAL PRESERVATIVES (2)

Improved ceramic microspheres obtained via one step « cleantech » manufacturing process : Pyrolyse pulvérisée®

1 to N compounds DRYING DECOMPOSITION DENSIFICATION

• Mineral microspheres at the heart of the « Pylote effect »

• Micron average size & narrow size distribution

Materials integration• Microspheres are integrated directly to final product materials by using the existing manufacturing process (like colorant in plastics transformation).

Strains C T0 C 24h A 24hLog

reduction per cm2

S. aureusCIP 53156

4.10 ± 0.09

3.56 ± 0.12

< 0.65 ± 1.12 > 2.9

E. coliCIP 53126

4.00 ± 0.03

4.17 ± 1.59

0.00 ± 0.00 > 4.2

EXISTING MANUFACTURING PROCESS

Contamination

Standard

Pylote Added

100%

0%

Weeks

New addition to ARGO’S TE030 Series

ARGO TE030 series was developed in 2014 and consisted initially of two vials, 10ml and 15ml, together with the common nozzle and cap. Following its successful course the series is growing with the recent addition of a 5ml vial. It is available in white and transparent, produced in ARGO’s Clean Room (ISO 7) and offered – if required – sterilized by gamma irradiation.

ARGO’s standard nasal spray (15ml) has been selected by Global Napi Pharmaceuticals for its product Deltarhino, which is a topical nasal decongestant containing Ephedrine hydrochloride & Naphazoline nitrate. The set belongs to ARGO’s Sprayers Squeeze NS60 series, also comprising a 30ml bottle (apart from the selected 15ml bottle).

The set consists of a printed bottle, an assembled sprayer and the corresponding cap. It is produced in ARGO’s ISO15378:2011 certified production area. Deltarhino sells almost 1.2 million units in the Egyptian market and is prescribed by General and Family Practitioners as well as ENT Specialists.

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Deltarhino Nasal Spray of Global Napi Pharmaceuticals

Drug Master File (DMF)A Drug Master File (DMF) is a set of documents, which is submitted to the US Food and Drug Administration (FDA) and may be used to provide confidential detailed information about facilities, processes or items used in the manufacturing, processing, packaging and storing of one or more human drugs. ARGO, as a supplier of packaging materials for pharmaceutical products, has already submitted since 2007 a DMF file for certain products (vials, caps, plugs, nozzles, jars, bottles, dosing units and cream applicators), which includes the following data:

The DMF is reviewed on annual basis and allows ARGO’s customers an easy access to all necessary information regarding the packaging of their products, that are released on the US market.

• Detailed product list• Detailed specification of each packaging material• Drawing of each packaging material• Raw material documentation• Presentation of ARGO • Quality Certificates of ARGO • Details about the sterilization subcontractors and their certificates.

Internal TrainingARGO’s policy, in all the years of its course, is to carry its commitments in the time promised. For this purpose, the company uses state-of-the-art equipment and continuously invests in this sector according to the latest standards. Nonetheless, believing that its success is at large affected by the skills of its workforce, the company gives great emphasis on the evaluation, continuous training and safety of its personnel, which consists of experts and scientists with sound technical and academic training and experience. In 2016 ARGO recruited eight new engineers with technical and academic education and implemented 22 internal and external training sessions by experienced instructors, such as:

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Retraining engineers and executives of R & D by a specialist from NISSEI Company on issues related to the production process of injection stretch blow molding.

Internal training of the Commercial Department from ARGO’s R & D Manager, on the production processes and properties of basic raw materials that are used.

ARGO’s personnel is considered to be the most important capital and contributes daily to the achievement of the

company’s business goals and flexibility in a continuously changing business environment.

New additions to UN certified ARGO bottles

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A UN package that has been certified by an accredited third-party for the transportation of dangerous goods bears the relevant UN mark:

The newest additions refer to a HDPE 4l canister with view stripe and a COEX 750ml bottle.

According to UN Recommendations on the Transport of Dangerous Goods, each substance is classified to Packing Groups based on its transportation risk and then the performance standards of a package per Packing Group are set. ARGO’s portfolio for UN certified packages includes many bottles and canisters:

ARGO makes sure that with the systematically performed controls all UN certified packaging materials conform to the strictest specifications, so as to guarantee the safety of everyone involved into the distribution chain of the final product.

3H1: Plastic jerricans with non removable head

Y1,3 : Y, type of packaging group / 1,3 kg/m3 maximum density

150: Internal pressure in Kpa

16: Year of manufacture

ARGO : Name of Producer

04282: Certification Code

H/VIII-S-001: Country and name of the Body that certified the packaging

2/12 : Month and year of Certification

‣ Canister 63 5L

HDPE (monolayer) Natural, white, other colors 240,0 63 / 63VTE

HDPE / PA (Coex) Natural, white, other colors 240,0 63 / 63VTE

‣ Stackable Canister 10L

HDPE (monolayer) White 420 DIN45

‣ Bottle Agrochem 50 1L

HDPE (monolayer) Natural, white 83,0 50

HDPE / PA (Coex) Natural, white 90,0 50

‣ Bottle Agrochem 50VTE 1L

HDPE (monolayer) Natural, white 75,0 50VTE

HDPE / PA (Coex) Natural, white 75,0 50VTE

‣ Bottle Agrochem PET 45VTE 1L

PET White 75,0 45VTE

Material Shade Weight Closure

New PET 3-5LCanisters

M-JARSfor Fertilizers

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Biomega is active in the production and trading of fertiliz-ers. Having as a main goal to maintain high standards of its products, to further grow its exports, Biomega has trusted since the beginning of 2016 the sourcing of the plastic packaging materials to ARGO. The 1 liter M jar was the choice of Biomega for the packaging of their liquid fertili-zers.The M jars of ARGO with capacities from 60ml to 1000ml, are made of HDPE and fit with the appropriate M closures (tear-off band), which are Snap-On &flip-top for easy use and tamper evident for the protection of the product.

At ARGO we always follow the current market trends with main focus to cover our customers’ needs. Our new range of PET canisters with volumes at 3L and 5L has been recently developed and is already in production. The canisters are capped with our 63mm closure (with I.S. liner / with or without T.E.) and offered with a handle for easy transport and use. The packaging solutions made of Polyethylene Τerephthalate (PET) are suitable for vari-ous crop protection products, such as pesticides, insecti-cides and herbicides. If requested, customized colors can be of an option, to either of the three components.

Coming soon…Stay tuned…

Breakthroughin the printing of Plastic Tubes!

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ARGO takes the next step in the printing of plastic tubes with a new technique that achieves ultimate photographic resolution and satisfies your needs for the most demanding artwork by combining flexo-graphy, silk screen and foil printing of metallized images.

At the beginning of 2017 the first printing machine in Greece using such technology in plastic tubes, and one of the few in Europe, will arrive at ARGO’s plant in Athens!

packaging solutions for successful products

ARGO S.A. 1st km Koropiou - Varis str., P.0.BOX 87, 19400 Koropi, Greece Tel. 0030 216 4003100Fax: 0030 210 6625500 e-mail: sales@argo-sa.gr

ARGOROM PLASTICS S.A. 211 - 249 Drumul Dealul Bradului str., Sect. 4 Bucharest, Romania Tel. 0040 215 393262 - 7 Fax: 0040 215 393264 e-mail: argorom@argo-sa.gr

w w w.argo-sa.gr

GREECE

ROMANIA