Macopharma
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PRODUCTS DESCRIPTION & SPECIFICATIONS

A technology based purely on light

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Platform overview

The THERAFLEX UV-Platelets system comprises a set of core components supplied by Macopharma, along with generic devices such as printers and a networked PC to host the MacoTrace software.

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Sterile connection device

MacoSeal

MacoTronic UV

Label printer

Report printer

MacoTrace

Disposable set

A transfer line, clamps, an illumination bag, a storage bag and a satellite bag are all provided as a disposal set for transferring the platelet concentrate.

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Transfer line for sterile connection
Blue Robert re-openable Clamps
Illumination bag (E.V.A)
A plug in the outlet port protector of the illumination bag
Port protector
Bactivam (Sampling pouch)
Red one-way permanent clamp

MacoTronic UV

Designed and manufactured by Macopharma, the MacoTronic UV is the heart of the THERAFLEX UV-Platelets system. Easy to operate, the benchtop device inactivates bacteria and pathogens by exposing the platelet concentrates UV-C rays.

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Specifications

MacoTronic
Capacity 1 bag / cycle
Illumination time < 1 min
Dose 0.2 J/cm2
Optical blocks 2 optical modules (3 UV tubes / module) UVC light
Agitation plate Orbital movement 180 rpm
Wavelength 254 nm ± 10 nm
Dimensions 87 (L) x 64 (W) x 38 (H) cm
Weight 67 kg
Communication outputs Ethernet connection for report printer,
USB connection for barcode reader,
USB connection for label printer,
USB connections (if required)
Accessories included Report printer, label printer, barcode reader, and bag holder

The MacoSeal TWIN EVA LIGHT

Specifically designed for the illumination bag, the MacoSeal TWIN EVA LIGHT ensures an effective seal at the top of the illumination bag (non-PVC container). A separate sealer is used for the PVC tubing.

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Sealer for E.V.A. bag (yellow colour in the bottom part)
Use this one to seal the top of the illumination bag.

Sealer for P.V.C. (blue colour in the bottom part)
This sealer is used to seal PVC tubing.

Position of the sealer :
the head of the sealer should
be completely inserted.

Inactivation process

With the THERAFLEX UV-Platelet system, bacteria and pathogens are inactivated by an intuitive eight-step process in less than 10 minutes:

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Step 1

The platelet concentrates to be treated are checked, to ensure they meet the required specifications in terms of volume and content.

Step 2

The packaging and bag are checked to ensure they have not been opened or tampered with. A further check is made to ensure the outlet port protector of the illumination bag is locked.

Step 3

A sterile connection device is used to connect the platelet bag to the illumination bag. The storage bag is identified and labeled, according to the local protocol.

Step 4

The platelet bag is suspended, the sterile connection is opened and the concentrate is allowed to transfer from one bag to the other. Air is purged from the illumination bag and the clamp is closed.

Step 5

The corner of the illumination bag is sealed – Macopharma recommends using the MacoSeal TWIN EVA LIGHT for this process – and the MacoTronic illumination device is switched on.

Step 6

The illumination and storage bags are placed in position, the barcode on the storage bag is scanned and the drawer of the MacoTronic is closed. The Start button is pressed and, once the illumination has been completed, the pack is removed. The report and label are printed.

Step 7

The illumination bag is suspended and the inactivated platelet concentrate is transferred to the storage bag. Air is purged from the storage bag, the clamp is closed and the transfer tubing is sealed off.

Step 8

The bag is ready to be used. Sampling may be carried out, if required, using the satellite bag provided.

Technical data

Macopharma has identified volume specifications and inactivation performance for the THERAFLEX UV-Platelets.

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Inactivation performance

  • Investigations on Mers-Cov, Ebola, Yellow Fever & FCV (model HEV) are completed / presentation during ISBT Toronto
  • On-going investigation on JEV, SARS, HEV etc…
Parasites ( 1.4 > 5 logs)
T. cruzi (Chagas Disease)
L. infantum
B. divergens
P. falciparum
Bacteria (> 4 – 5 logs)
S. epidermidis C. perfringens
K. pneumoniae P. fluorescens
S. aureus L. monocytogenes
P. acnes St. pyogenes
E. cloacae A. baumannii
P. aeruginosa St. agalactiae
B. cereus St. bovis
E. coli St. dysgalactiae
S. marcescens St. pneumoniae
Leukocytes (> 5 logs)
In vitro (Proliferation/Limiting dilution assay, Cytokine release)
In vivo (Mouse Model)
Viruses (3 > 6 logs)
West Nile Virus (WNV)
Sindbis virus (SIN)
Hepatitis C virus (HCV)
Vesicular stomatitis virus (VSV)
Suid herpesvirus 1 (SHV-1)
Encephalomyocarditis virus (EMCV)
Porcine Parvovirus (PPV)
Influenza (H3N2)
Dengue 1-4 (DENV)
Hepatitis A (HAV)
Ross River (RRV)
Chikungunya (CHIKV)
ZIKA (ZKV)

Volumes specifications

Small volumes 230-320mL (e.g. paediatric use) validation is in progress

Parameters Specification A
(Standard plasma carry-over)
Specification B
(Low plasma carry-over)
Volume (mL) 325 – 450
Plasma carry-over (%) 30-40 25-35
Ratio plasma: SSP+ (%) 60-70 65-75
Platelet concentration (109/mL) 0.8 – 1.4 0.7 – 1.4
Platelet count (1011/unit) 2.60 – 5.25 2.28 – 5.25
Residual WBC (106/unit) < 1 < 1