BI Placed Inside Middle of Packaged Gown: All Equipment Was Within Calibration and Commissioning Requirements

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- m bo v trng (Sterile Assurance Level - SAL)

- Liu x kh trng (Dkt)


- Fractional : phan doan
- internal process challenge devices (IPCD) : thiet bi thach thuc qua trinh ben trong
- external process challenge devices (EPCD) : thiet bi thach thuc qua trinh ben ngoai
- the adequacy of the recovery technique of the surviving spores
surviving spores : bao tu song
adequacy : phu hop
recovery technique : ky thuat phuc hoi
resistant : khang cu
* maximum load half cycles
* minimum load half cycle
- conduct : thuc hien, tien hanh
a) IPCD -- > no growth of the biological indicator organism : khong phat trien duong tinh cua
BI
BI placed inside middle of packaged gown

b) EPCD -- > acceptable results


BI placed into F.C. sealed pouch film and placed into F.C. sealed pouch film one more time(total 3 layers
of FC) and then placed inside Bemis pouch

* full cycle -- > the requirements for residual levels of ethylene oxide and ethylene chlorohydrin
are met according to ISO10993-7:2008

=> All the cycle runs and testing results met all the acceptance criteria specified in the
validation protocol.

The validation cycle parameters : thong so cua chu ky khu trung


All equipment was within calibration and commissioning requirements : yu cau vn hnh th
v hiu chun
* Sterilizing Agent Characterization : c tnh ca cht kh trng
80/20 CO2/EO is used for sterilization. Certificates of analysis are available at NTI-VINA.
1.1. Products to be Validated
2. Product Sterility Testing: kim tra v trng ca sn phm. -- > fractional cycle chu k
phn on
- bacteriostasis/fungistasis testing --> contact on product
3. Product Ethylene Oxide Residual Levels --> ISO 10993-7
the worst case : trng hp xu nht
4. Product Packaging Validation
- configuration : cu hnh
- dwell time : thi gian dng
- negative results : m tnh
- Microbiological aspects : kha cnh vi sinh
- incubation time : thi gian

AQL : http://www.aimcontrolgroup.com/eg/n/604/0/aql-chart-for-the-fashion-industry-&-
qa/qc-inspection.htm

Mr. Yoo
+84 1672274076
+84 1672380503

C/O cho chau au --> giam thue


tong gia tri vat tu (khong r nguon goc xuat xu bao gom trong va ngoai nuoc) <
40% tong gia tri cua hang hoa.

1. Adhesive Incise: single sinded tape


2. OP Tape Strips: double-sided tape

* albis : original cost: USD 5.6 -- > margin 6.61%

This video contains footage some viewers may find upsetting

Material characteristic:
1) SPP: (20gsm - 80gsm)
- breathable
- Non-toxic
- Comfortable
- SBPP: soft spunponded polypropylene

MSDS sheets must contain:


1. Name of the chemical;
2. Manufacturers information;
3. Hazardous ingredients/identity information;
4. Physical/chemical characteristics;
5. Fire and explosion hazard data;
6. Reactivity data;
7. Health hazard data;
8. Precautions for safe handling and use; and
9. Control measures.

Physical properties l nhng c tnh vt l ca 1 vt cht, gm c rt nhiu tnh cht.


Sau y l 1 s tnh cht vt l thng c quan st, th nghim:
Absorption: Tnh thm thu ( ht cht lng, cht kh)
Albedo: Tnh phn quang, phn chiu
Boiling point: Nhit si
Color: Mu sc
Concentration: tp hp
Conductance: Sc dn in
Density: m c
Ductility: do
Distribution: phn tn
Emission: phng nng lng ca ht nguyn t
Fluidity: di chuyn ( trong trng thi lng, nng chy)
Freezing point: ng thnh
Hardness: cng
Magnetic field / flux: gi, cm nhim t trng
Melting point: tan chy
Resistance: Sc cn in, in tr
Smell: Mi
Solubility: ha tan
Strength: bn. Gm c yield strength: Sc chu lc nn n khi cong, v ultimate
strength: Sc chu lc nn n khi rn nt hoc gy
Tension: cng
Thermal expension: dn n khi nhit tng
Thermal transfer: Tc truyn, chuyn nhit ( nhanh hoc chm)

MEDICOS Surgical Gown - AAMI Level 3 SMMMS

1. Direct cost
- Fabric cost: 57%
- Component 9%
- Direct labor cost: 9%
- Packaging cost: 14%
- Sterilization cost:1%
- Logistic cost: 2%
2. Indirect cost
- indirect labor: 56%
- overhead 46%
3. Margin 17%

Pls refer inf as below:


Ocean Freight: $90/120/120 per 20GP/40GP/40HQ
Local charge in Vietnam:
THC: $110/$160/$160 per 20GP/40GP/40HQ
DOC FEE: $35/SET
TLX: $25/SET
HD/L: $30/SET
------------------
Thu 3: gia va spec
Thu 4: gui mau

--------------------------------

- NTI password: ntivina@12345


- NTIVINA password: ntivina123456

CAH Conferencal call


ID: Mediprotek@mediprotek.onmicrosoft.com
passW: Admin1234
Skype for business

Laptop
Username : hirugohan
Email pass : 2222

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