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The IMGSA Review

THE IMGSA INSGHIT 2017 EDITION No. 01

INAUGURATION OF IMGSA GROUP TRAINING HUMAN POTENTIAL, A CONCERN

MEDICAL GLOVES MANUFACTURING OF THE GROUP
As the manufacture of gloves is a first in Algeria, the training
COMPLEX BY MR PRIME MINISTER of staff is one of the priorities of the group IMGSA. She inter-
venes during the hiring and during all the professional period
of the employees. Page 05
On Thursday, July 14, 2016, Prime Minister
Abdelmalek SELLAL together with sever-
al members of the government and in the
presence of local authorities of the wilaya,
inaugurated the complex of manufacturing
medical devices, located in the industrial area
of Ouled
​​ Gacem,
page 02
Page 02
The IMGSA INSIGHT Review of 2017

LETTER OF THE INAUGURATION OF IMGSA GROUP

PRESIDENT
OF THE IMGSA MEDICAL GLOVES MANUFACTURING
GROUP
COMPLEX BY MR PRIME MINISTER
“Being founder and President of a
pharmaceutical group of international
stature and key link in the chain of On Thursday, July 14, 2106, Prime Minister Abdelmalek SELLAL together with several members of the government and in the
public health, imposes a very strict
entrepreneurial and managerial conduct
presence of local authorities of the wilaya,
confirming the steps already taken for
the development of our medical glove
production units. and our flagship July, 2016
product Gant H.
I have invested myself personally in
mastering this unique technology, in
order to meet international standards
On Thursday, July 14,
in this area and be at the rendezvous of 2016, Prime Minister Ab-
a national economic climate favorable
to industrial investments. delmalek SELLAL togeth-
The contribution of our group to the er with several members
development of our country, which is
an asset, is not only based on its ability of the government and
to create wealth through the goods and
jobs it generates, it has also engaged in
in the presence of local
investing in the training of the country. authorities of the wilaya,
human potential through the conditions
and tools of work put at their disposal. inaugurated the complex
I remain convinced that the group’s
employees share my desire to grow our
of manufacturing medical
business. Their interests will always be devices, located in the in-
at the center of my concerns and a prior-
ity because our profits are the salvation dustrial area of ​​Ouled Ga-
of our families and our children. cem, Ain M ‘lila, Wilaya
As far as our products are concerned,
our group has set up a system of or- of Oum El Bouaghi. It is
ganization and guidance defining and
specifying the quality management
the largest single com-
system requirements, to ensure that our plex of its kind whose
products are in line with the needs of
our customers. partners. production capacities far
I will share with our clients certainty,
clarity and transparency to preserve our
exceed national needs. The
common interests and deal with any complex produces sterile
adverse economic conditions.
Aware of the stakes of the market and latex medical examination
Mister Prime Minister inogurating the complexe
the specific pharmaceutical character of gloves, products whose
our products, our exclusive distributors
must fulfill the technical and regulatory needs were imported. The On Thursday, July 14, 2106, Prime Minister Abdelmalek SELLAL together with several members
conditions for a sustainable partnership of the government and in the presence of local authorities of the wilaya,
and meet our expectations in terms of
complex will also produce
services and prices to establish with nitrile medical gloves. ment to investors so that the ability of Algerian firms medical gloves through
them a reliable network along the
way. term. Mr. Prime Minister was they can find all kinds of to compete with foreign the Central Pharmacy of
I promise you, as the Group’s leader,
to be self-sacrificing in order to further
delighted on site the level facilities that encourage products. the Hospitals.
develop our wealth, which has all the re- of technology of the com- them to invest. The inau- Thanks to this complex
quired standards and to steer us towards
new international trading horizons. plex and the quality of the guration of this complex meeting international stan-
gloves manufactured. He by the Prime Minister dards, the national cov-
Ceo and Founder of the Group
took the opportunity to demonstrates the confi- erage has been covered
recall the state’s commit- dence of the authorities in and Algeria imports more

PARTNERSHIP
WITH CUBA.
M r. President of in exchange for im-
porting their drugs
IMGSA Group ac-
Biotechnology-de-
companied the Prime
rived blood products,
Minister during his
as part of the product
official visit to Cuba
exchange procedure,
in October 2016 in the
which will preserve
context of trade with
the country’s foreign
this country.
exchange reserves.
In this context and
For its part, the Di-
after intense negotia-
rectorate General of
tions with the Cuban
Customs has signi-
company FARMACU-
fied its agreement for
BA, the IMGSA group
these exchange oper-
has signed a letter of
ations products.
intent, to market the
Glove H (sterile and
Signing of the agreement examination) in Cuba
 The IMGSA INSIGHT
PAGE 03
PRESENTATION OF THE GROUP
It is an Algerian fam-
ily-owned company
called IMGSA Pharma-
ceutical Industry Group,
set up on own funds in
SPA, with a registered
capital of 500,000,000
AD.
The group IMGSA or-
ganized around a Gen-
eral Management in Al-
giers, has:
A complex of manu-
facturing medical gloves
(latex and nitrile) in
Ouled Gacem, Ain M’li-
la, Wilaya of Oum El
Bouaghi.
An injectable ceph-
alosporin manufactur-
ing unit still in progress
in Ain Mlila, wilaya of
Oum El Bouaghi.
The glove manufactur-
ing complex was com-
pleted in 24 months, with
a cost of three (03) billion
DA for the entire project.
This is a pharmaceutical
complex approved by the
Ministry of Health on
February 13, 2013.
The complex comprises
three (03) Glove produc-
tion units, each of which
has two production lines.
The central pharmacy of hospital is the main national cus-
tomer of IMGSA Group which takes the responsability to
provide all the hospitals (public or private ) with all kind
of medicaments and medical devices.
1st production unit with ble production capacity.
an area of 5000
​​ m2, with
two (02) production lines. 3rd production unit in
project whose reception
2nd production unit of is planned for the year
5000 m2, with two pro- 2018.
duction lines with a dou- The complex operates
PHARMACIE CENTRALE DES HOPITAUX,
FIRST NATIONAL PARTNER.
The Central Hospital Pharmacy (PCH) is our first national partner
The Central Hospi-
tal Pharmacy (PCH)
is our first national
partner because of its
status as a central pur-
photo of PCH
chasing agency for
all public and private
hospitals. The IMGSA
The Gloves Factory Training Center
with a continuous diet
with three teams (3X8h)
with a production capac-
ity of 200,000 pairs of
sterile gloves / day and
1,000,000 examination
gloves / day.
group is currently the human and material
only supplier of PCH resources.
medical gloves that
no longer uses import,
with a delivery sched-
ule and a daily and reg-
ular supply, by putting
in place the necessary
REVIEW OF 2017
THE
QUALITY
SYSTEM
OF THE
GROUP
Quality assurance remains our policy
to ensure the quality of the products
placed on the market with the presenta-
tion of the company, the quality system,
the procedures, the certifications, as
well as the results of quality controls
and quality audits.
Thus, all the prerequisite and system-
atic activities have been implemented
through our quality assurance depart-
ment by procedures for the objectives
achieved in terms of quality and the
methods used to achieve these objec-
tives.
In addition, our group has worked
since the realization of the project to
the implementation of international
standards standards through:
1. An organization and guidance
system defining and specifying quality
management system requirements, to
ensure that our products are in line
with customer needs (ISO 9001/2015
certification).
2. This certification sets out require-
ments for the quality management sys-
tem of medical devices in the design,
development, production, storage and
distribution stages (ISO 13485: 2016
certification).
3. specifies the requirements for the
development, validation and routine
control of the sterilization process
for ethylene oxide medical devices in
industry and health facilities, and rec-
ognizes the similarities and differences
between the two certification applica-
tions (ISO 11135: 2014).
4. Guided by an eco-citizen mo-
mentum, several actions have been
undertaken by the group to contribute
to the preservation of the environment,
including the management and circu-
lation of chemical materials and the
water recovery system through a cir-
cuit internal. This is an environmental
action (ISO 14001: 2015 certification)
PAGE 04
The IMGSA INSIGHT Review 2017

VISIT OF THE ANNABA’S CONSUL OF

FRANCE TO THE COMPLEX.

The French consul in Annaba visited the

group’s medical glove production com-
plex in Ain M’lila. During this visit, the
French consul was impressed by the facil-
ities of the complex, including the level
reached by an Algerian company in this
area of production
​​ in terms of internation-
al standards.
He also affirmed his willingness to work
to find partnerships with French compa-
nies through the medication and linking of
its services, for the export of our brand of
gloves to France.
Page 05
TRAINING HUMAN
POTENTIAL, A CONCERN
OF THE GROUP
As the manufacture of
gloves is a first in Algeria,
the training of staff is one
of the priorities of the
group IMGSA. She inter-
venes during the hiring
and during all the pro-
fessional period of the
employees.
It remains a means to
sustain professional proj-
ects, to achieve the defined
objectives, update, orga-
nize and broaden staff
knowledge in this special-
ty.
For the purpose of
accompanying the group
IMGSA investments in
pharmaceuticals, a mod-
ern training center with
three levels has been
achieved, with all ameni-
ties and equipped with lat-
est equipment to provide a
potential human potential
to support the operation of
such investments.
As such, training is pro-
vided locally and abroad
by national and foreign
experts in various fields of
training:
. Through continuing
education plans validated
The IMGSA INSIGHT Review of 2017
by these experts.
. By objective evaluation
to acquire new knowledge
. Staff development
towards new responsibil-
ities and career develop-
ment within the company.
In terms of the training,
the IMGSA group devel-
oped a training plan affect-
Meeting with The CEO of the group
ing all sectors that have a
direct or indirect relation-
ship with the pharmaceu-
tical industry: Basic train-
ing with GMP and GMP
Introduction to the quality
and control Introduction
to ISO, Introduction
to the manufacture of
sterile products, train-
ing standards of Health,
Safety and Environment
(HSE), Information sys-
tems Training, language
Training (English).
Training room
THE
GROUP
CONTROL
CENTER
The Group has a com-
puter control center for
all activities of the com-
plex’s units with:Con-
trol of receipt of inputs.
Control of production
operations
Control of sterilization
of products.
Control of material and
merchandise flows.
Flow control at the input
and output of the unit.
Control of staff flows
across all the sites of
the unit.
Control room
Page 06
QUALITY CONTROL.
At the level of the units cur-
rently in production, upstream
control of raw materials and
downstream control of the fin-
ished product are carried out.
Added to this is the in process
control during the different
production stages according to
the international standards of
controls:
1. Laboratory of physico-
chemical control, validated by
the National Laboratory for
the Control of Pharmaceutical
Products (LNCPP), for all tests.
2. Microbiological control
laboratory, for sterility testing,
validated by the LNCPP.
THE QUALITY SYSTEM OF THE GROUP
Quality assurance remains our
policy to ensure the quality of the
products placed on the market with
the presentation of the company, the
quality system, the procedures, the
certifications, as well as the results
of quality controls and quality audits.
Thus, all the prerequisite and sys-
tematic activities have been imple-
mented through our quality assurance
department by procedures for the
objectives achieved in terms of quality
and the methods used to achieve these
objectives.
In addition, our group has worked
since the realization of the project to
the implementation of international
standards standards through:
1. An organization and guidance
system defining and specifying quality
management system requirements, to
ensure that our products are in line
with customer needs (ISO 9001/2015
certification).
2. This certification sets out require-
ments for the quality management sys-
tem of medical devices in the design,
STUDY DAY ORGANIZED BY IMGSA and the resorption of
IN AIN M’LILA WITH THE BNA unemployment by the
The group IMGSA
organized on Sun-
day, May 21, 2017,
under the presiden-
cy of Mr. Wali of
the Wilaya of Oum
El Bouaghi, a study
day at the level of
the production unit,
a study day under
the theme “ Contri-
bution of the IMG-
SA group and the
National Bank of
Algeria in pharma-
ceutical industrial
investment in the
The IMGSA INSIGHT
development, production, storage and
distribution stages (ISO 13485: 2016
certification).
3. specifies the requirements for the
development, validation and routine
control of the sterilization process
for ethylene oxide medical devices
in industry and health facilities, and
recognizes the similarities and differ-
ences between the two certification
applications (ISO 11135: 2014).
4. Guided by an eco-citizen mo-
mentum, several actions have been
undertaken by the group to contribute
to the preservation of the environment,
including the management and circu-
lation of chemical materials and the
water recovery system through a cir-
cuit internal. This is an environmental
action (ISO 14001: 2015 certification)
wilaya of Oum El
Bouaghi “.
Information was
given to all partici-
pants on this day on
the steps leading to
the implementation
of such an invest-
ment, as well as the
constraints encoun-
tered. Moreover, it
was specified during
this event the import-
ant role of the group
in the development of
this wilaya through
this industrial tool
Review of 2017
STARTING THE LAST
GENERATION GLOVES
MANUFACTURING LINE
Written by
H.CHERGUI
Factory
Manager
The manufacturing pro-
cess of medical gloves is
very complicated one,
and this depend on many
aspects, like quantity ,
quality, continuity …etc
producing more gloves
allows the availability of
the product and this will
depend on the size and
the quality of the man-
ufacturing line, our new
line is one of the latest
full automated double
former lines which can Fully automated line
produce big quantity and the quality of the manufacturing line, our new line is one of the latest
have all the required set- full automated double former lines which can produce big quantity and
have all the required settings to make very high quality product
tings to make very high
duction of the gloves duction process finishes
quality product , with ca-
within our factory many taking the gloves out of
pacity of around 12000
steps forward. as this the line process is called
former , this line can
line can produce all kind <stripping process> for
produce up to 500.000
of natural rubber gloves this line it is made au-
which increase our pro-
( powdered and non tomatically by blowing
duction capacity to 1.5
powdered examination the dried air into the
million pcs of examina-
and surgical gloves). formers to seperate them
tion gloves per day and
equipied with autmat- and then take them to the
around 250 thousand
ic tempurature control next step depending on
pairs of surgical gloves
system which allows the type of the gloves.
daily, the startup of this
best curing conditions
line boosted the pro-
of the gloves after pro-
creation of more than
250 job positions
Mr. Chairman and
Managing Director of
the National Bank of
Algeria who took part
in this event want-
ed to emphasize the
contribution of such
an investment in this
locality, and the fi-
nancial arrangement
on own funds.
\Algeria, BNA and IMGSA Flags
Mr. Chairman and Managing Director of the National Bank of Algeria who
took part in this event wanted to emphasize the contribution of such an investment
Page 07 The IMGSA INSIGHT Review of 2017

ISO certificate 14000:2015 ISO certificate 13485:2016

Obtention of
ISO
certificatates
being in international
level business requires
many important things
among them is to be
certified according to
the international stan-
dards, and this what
IMGSA have achieved,
our group is certified by
ISO 9001:2015 as well
as the 14000:2015 and
13485:2016 and last
11135:2014 in addition
to that oour quality con-
trol system response to
the need of all the stan-
dards that are related
to the gloves industrie
which allow us to be
among the best and lead
ISO certificate 9001:2015 ISO certificate 11135:2014 this industry in the future
Page 08 The IMGSA INSIGHT Review of 2017

The Sterilization Process

There are many advantages to understanding
an ethylene oxide (EO or EtO) sterilization
process when considering the different steriliza-
tion options. A knowledge of the process may
prevent unnecessary product testing or may
identify product changes which may be required
prior to attempting to sterilize with EO. The fol-
lowing information, although generic in nature,
is designed to provide basic information on the
ethylene oxide sterilization process.
Our factory used 10M3 and 20 M3 sterilizers
with capacity of 200.000 pairs per cycle , this is
biref description how it works:
The EO sterilization process has been
employed by the health care industry to sterilize
medical devices since the early 1940s (Griffith
and Hall – 1940, 1943)1. Although not as well
controlled as the processes of today, the anat-
omy of the process itself remains remarkably
similar to the earlier process designs. One can
attribute these similarities to the nature of the
gas itself.
Simple But Effective
Using a vacuum-tight chamber, an initial
vacuum is drawn to remove air and prevent
an unsafe mixture when EO is injected. After
the vacuum is complete, moisture, usually in
the form of steam, is added to the chamber to
replace that moisture which is lost during the
initial vacuum phase.
Next in the sequence is the introduction of
the ethylene oxide gas to a predetermined con-
centration. The concentration has been selected
to assure an adequate sterilization process is
delivered. Finally, after the product is allowed
to soak in the EO for a controlled and prede-
termined amount of time, a series of washes is
performed to rid the chamber of the EO. A wash
consists of pulling a vacuum followed by a
pressurization with an inert gas, which is usual-
ly nitrogen. The vacuum and pressurization pro-
cesses are repeated for a predetermined number
of repetitions until the chamber atmosphere is
below the flammability limit of 3% for EO.
A Simple EO Process In Detail
1. Environmental Preconditioning
Most of the EO sterilization processes of
today start with conditioning of the products
to be sterilized outside of the sterilization
chamber. Preconditioning is usually performed
in a room which has been specially designed to
heat and humidify the products to a stable inter-
nal temperature and moisture content prior to
entering the chamber. This will assure that the
sterilization process is reproducible regardless
of external influences such as varying climatic
conditions.
Items for consideration:
2. Initial Evacuation
To safely deliver the 100% ethylene oxide
process, at least 97 percent of the air must be
removed from the chamber. Today, the two
most common methods of accomplishing this
requirement are (1) pulling a deep vacuum,
or (2) performing a series of partial vacuums
followed by a series of nitrogen injections.
This combination, when performed using an
adequate number of repetitions, will purge
(remove) the air, thus allowing the process to
be performed safely.
3. Humidification
The total inactivation of microorganisms
using ethylene oxide is attained when sterilizing
conditions are met within the chamber. The four
active ingredients required to deliver a success-
ful process are:
Heat
Moisture
Gas concentration
Time
4. Gas Injections
After the humidification phase, liquid eth-
ylene oxide is first heated into a gaseous phase,
then injected into the chamber. The amount of
gas or gas concentration3 is dependent on two
primary factors which are addressed during
cycle design.
5. Postexposure Gas Purge and Air Inbleed
After the exposure phase of the process, all
gas must be removed from the chamber until
the levels of EO fall below the flammable
limit for the gas (3 percent or 30,000 ppm).
This is accomplished by performing a series of
post-vacuums, each followed with a nitrogen
backfill (wash).

The Biggest clean

room in the gloves
industry
The importance of a are designed according
cleanroom in the gloves to Mr ceo requirments
industry can not be to meet the needed
under estimated espe- efficency. working in
cially to produce the highly strict conditions
sugrical sterile gloves. oue staff are trained to

our organization knows handle these machines

the big importance this with high profission-
kind of gloves must cy. the daily output is
be processed in 0 germ around 240.000 pairs
and 0 dust environment. in diffrent sizes after
with surface of more that they pass to the
than 1000 sq meters next step which will be
our clean room is con- packing the gloves in
sidered as one of the the boxes and cartons
biggest if not the big- before go to the steril-
gest one, it is equippied ization process
with fully automated
packing ( blister and
pouch machines) that

EXPORTATION OF GANT the unit of produc-

tion of Ain M’lila
H TO TUNISIA. close to 30% of the
this country for total market.
The IMGSA an amount of 1.5
group has signed Million Euros for
an agreement with the financial year
a Tunisian partner 2018. Several
Photo Credit 3
for the export of deliveries have
medical gloves to been made from